FDA 510(k) Applications Received During September, 1981

FDA 510(k) Number Submission Date Device Name Applicant Contact
K812678 09/22/1981 TEGADERM TRANSPARENT DRESSING 3M COMPANY
K812697 09/22/1981 HEMA 20 MICRON TRANSFUSION BLOOD FILTER ABBOTT LABORATORIES
K812504 09/01/1981 ACCRA LAB WRIGHT STAIN ACCRA LABORATORIES, INC.
K812554 09/08/1981 TOMAC STERILE DISP. LAP SPONGE AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K812637 09/15/1981 ACMI BIPOLAR HEMOSTATIC SOURCE AMERICAN CYSTOCOPE MAKERS, INC.
K812583 09/10/1981 BOVINE CHEMISTRY CONTROL I.X. & II.X. AMERICAN DADE
K812556 09/08/1981 DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C AMERICAN DADE
K812541 09/04/1981 PROTEIN-BASED BLOOD GAS CONTROL AMERICAN DADE
K812563 09/08/1981 SWAN-GANZ & EDSLAB HEPARIN COATED CATH. AMERICAN EDWARDS LABORATORIES
K812695 09/22/1981 DISK AMERICAN HEARTLINE, INC.
K812567 09/09/1981 "RELIEF" AMERICAN PHARMACEUTICAL CO., INC.
K812621 09/15/1981 DELTA-A.V. FISTULA CANNULATION SET AMISCO TRADING CORP.
K812622 09/15/1981 HEMODIALYSIS VENOUS & ARTERIAL SET AMISCO TRADING CORP.
K812749 09/29/1981 ULTRA-DIG ANTIBODIES INC.
K812719 09/25/1981 PROSANA BELT BANDWAGON, INC.
K812571 09/09/1981 MEZLOCILLIN 75 MCG. SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812754 09/30/1981 BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN BECKMAN INSTRUMENTS, INC.
K812649 09/17/1981 BECKMAN ICS CALIBRATOR BECKMAN INSTRUMENTS, INC.
K812650 09/17/1981 BECKMAN ICS NORMAL CONTROL SERA BECKMAN INSTRUMENTS, INC.
K812582 09/10/1981 CANCEL BIO SYSTEMS, INC.
K812619 09/15/1981 ISOLATED VOLTAGE/FREQUENCY CONVERTER BIO-FEEDBACK SYSTEMS, INC.
K812643 09/16/1981 LIFESPAN CO2 BIOCHEM INTERNATIONAL, INC.
K812677 09/22/1981 UNITEST-POTASSIUM BIODYNAMICS CORP.
K812565 09/09/1981 ELUTION SOLUTION BIOLOGICAL CORP. OF AMERICA
K812530 09/02/1981 TRANSDUCER DOME BIOMEAL CORP.
K812538 09/03/1981 ELITE BIOTONE INTERNATIONAL, INC.
K812604 09/15/1981 BIOVATION URINALYSIS REPORTER BIOVATION, INC.
K812728 09/28/1981 FLEET DETECTATEST C.B. FLEET CO., INC.
K812702 09/23/1981 TECHNICATOR CAMERON-MILLER, INC.
K812668 09/21/1981 AFB STAIN SET CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
K812617 09/15/1981 VITROGEN TM 100 COLLAGEN CORP.
K812722 09/28/1981 SAFE GUARD CONCEPT, INC.
K812540 09/04/1981 CORDIA IM CORDIS CORP.
K812661 09/18/1981 IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA DAKO CORP.
K812662 09/18/1981 IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA DAKO CORP.
K812672 09/22/1981 SELF-CENTERING HIP DEPUY, INC.
K812638 09/15/1981 DIAGNOSTIC MEDICAL COMPUTER DIAGNOSTIC RESOURCES, INC.
K812515 09/02/1981 CARDIAC REVIEW STATION DIASONICS, INC.
K812525 09/02/1981 MEZLOCILLIN 75 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K812524 09/02/1981 PIPERACILLIN 100 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K812613 09/15/1981 VIDICAM 200 DIVERSIFIED P.A.
K812602 09/15/1981 RABBIT COAGULASE PLASMA DUTCHLAND LABORATORIES, INC.
K812522 09/02/1981 RABBIT COMPLEMENT DUTCHLAND LABORATORIES, INC.
K812506 09/01/1981 THE ARTHROFILE DYONICS, INC.
K812664 09/21/1981 "ACA" IMMUNOGLOBULIN G ANALYTICAL TEST E.I. DUPONT DE NEMOURS & CO., INC.
K812626 09/15/1981 ACA ANTITHROMBIN III PLASMINOGEN CALIB E.I. DUPONT DE NEMOURS & CO., INC.
K812627 09/15/1981 ACA ANTITHROMBIN III TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812628 09/15/1981 ACA FIBRINOGEN CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K812629 09/14/1981 ACA FIBRINOGEN TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812631 09/15/1981 ACA IMMUNOGLOBIN A TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812632 09/15/1981 ACA IMMUNOGLOBIN M TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812633 09/15/1981 ACA IMMUNOGLOBULIN A/M CALIBRATORS E.I. DUPONT DE NEMOURS & CO., INC.
K812630 09/15/1981 ACA IMMUNOGLOBULIN G CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K812625 09/15/1981 ACA PLASMINOGEN TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812535 09/03/1981 PLASTILIX MINIRAD D CASSETTE EASTMAN KODAK COMPANY
K812606 09/15/1981 SECTORTAC ECHO LABORATORIES, INC.
K812612 09/15/1981 TNS MK I STIMULATOR EDU KIT LTD.
K812674 09/22/1981 INFANT CARIDAC MONITOR ELECTROMED INTL., LTD.
K812635 09/15/1981 ANEMIA CONTROL ENVIRONMENTAL CHEMICAL SPECIALTIES
K812685 09/22/1981 ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE ERICKA
K812648 09/17/1981 EHTOX GASTRIC LAVAGE KIT #2050 & #2070 ETHOX CORP.
K812544 09/04/1981 RELIANCE OPHTHALMIC INSTRUMENT CONTROL F. & F. KOENIGKRAMER
K812553 09/08/1981 AQUEOUS BLOOD GAS CONTROLS FISHER SCIENTIFIC CO., LLC.
K812623 09/15/1981 CLEANING SOLUTION FOR RADIOMETER OSM2 FISHER SCIENTIFIC CO., LLC.
K812724 09/28/1981 RELAXATION TANK FLOAT-TO-RELAX, INC.
K812639 09/16/1981 UNICUFF FRONTIER PRODUCTS
K812568 09/09/1981 "CAVITRON" G-C INTL. CORP.
K812679 09/22/1981 G-C FIT-CHECKER IMPRESSION MATERIAL G-C INTL. CORP.
K812680 09/22/1981 G-C IMPRESSION SYRINGE G-C INTL. CORP.
K812600 09/14/1981 GER 540, GER 541 MANUAL BED G.W. HEALTHCARE, INC.
K812539 09/03/1981 PRE-BYPASS FILTER GELMAN SCIENCES, INC.
K812509 09/02/1981 CT/T 8800 GENERAL ELECTRIC CO.
K812561 09/08/1981 LATERAL ANGULATING FLUORO SUSPENSION SYS GENERAL ELECTRIC CO.
K812595 09/11/1981 ULTRA CHEM E-GLU #64976 & 65040 HARLECO
K812589 09/11/1981 ULTRA CHEM E-TRIG #65024 HARLECO
K812596 09/11/1981 ULTRA ZYME PLUS ALP #64962, 65029 & 30 HARLECO
K812594 09/11/1981 ULTRA ZYME PLUS AMYL #64982 & 65031 HARLECO
K812593 09/11/1981 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 HARLECO
K812592 09/11/1981 ULTRA ZYME PLUS GOT #64953, 65033 & 34 HARLECO
K812591 09/11/1981 ULTRA ZYME PLUS GPT, #64956, 65035 & 36 HARLECO
K812590 09/11/1981 ULTRA ZYME PLUS LDH #64950, 65038 & 39 HARLECO
K812507 09/01/1981 THE KEOFEED STOMACH TUBE HEDECO
K812533 09/02/1981 PLATELET AGITATOR HELMER LABS, INC.
K812687 09/22/1981 BRIGHAM II TOTAL HIP SYSTEM HEXCEL MEDICAL
K812669 09/21/1981 SEATTLE II TOTAL HIP SYSTEM HEXCEL MEDICAL
K812700 09/23/1981 URICAR HI CHEM, INC.
K812731 09/28/1981 SEPTI-CHECK BLOOD CULTURE SLIDE HOFFMANN-LA ROCHE, INC.
K812732 09/28/1981 SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE HOFFMANN-LA ROCHE, INC.
K812729 09/28/1981 SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE HOFFMANN-LA ROCHE, INC.
K812730 09/28/1981 SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE HOFFMANN-LA ROCHE, INC.
K812667 09/21/1981 MEDDARS/ULTRA IMAGER RESPIRATION MODULE HONEYWELL, INC.
K812575 09/09/1981 MODEL H12-10 HOSPAL MEDICAL CORP.
K812562 09/08/1981 SURGICAL RETRACTOR & ELASTIC STAYS, DISP HUMBOLDT PRODUCTS
K812597 09/14/1981 FERRITIN KIT HYBRITECH, INC.
K812727 09/28/1981 GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT IMMUNO NUCLEAR CORP.
K812750 09/29/1981 IL 703, STAT SEPARATOR INSTRUMENTATION LABORATORY CO.
K812756 09/30/1981 ADAPTAID #365-38 INTERMEDICS, INC.
K812502 09/01/1981 IMPLANTAID LEAD INTRODUCER #319-10 & 12 INTERMEDICS, INC.
K812755 09/30/1981 MODEL 535-03 TRACE A PACE INTERMEDICS, INC.
K812671 09/21/1981 EMBRITROL CK-MB CONTROLS INTL. IMMUNOASSAY LABORATORIES, INC.
K812675 09/22/1981 DISPOSABLE SURGICAL FACE MASKS IREMA USA LTD.
K812746 09/29/1981 THORACIC DRAINAGE SET #55-DB2-G J. H. EMERSON CO.
K812745 09/29/1981 WARMING LISTHTS #96H & 96HT J. H. EMERSON CO.
K812686 09/22/1981 SINUSCOPE JEDMED INSTRUMENT CO.
K812573 09/09/1981 SPIROMETER FILTER K & G HEALTHCARE IND., INC.
K812611 09/15/1981 QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO KALLESTAD LABORATORIES, INC.
K812586 09/11/1981 KANTRON 504 HEARTSTATION KANTRON CARDIOVASCULAR, INC.
K812587 09/11/1981 MONO 2 OXYGEN MONITOR KANTRON CARDIOVASCULAR, INC.
K812726 09/28/1981 KERMATH THERAPY SIMULATOR KERMATH MFG. CORP.
K812644 09/17/1981 REPLACEABLE BATTERY PERFECTEMP 2" CAUT KEY MEDICAL, INC.
K812521 09/02/1981 SUNTANNING DEVICE (SEPAR. FROM K812225) KLAFS SUNLIGHT CORP.
K812656 09/18/1981 DOTRICH ELECTRONIC AIR CLEANER #C500AM LEEDAL, INC.
K812693 09/28/1981 LIF-O-GEN #3000 OXYGEN CONCENTRATOR LIF-O-GEN, INC.
K812519 09/02/1981 2000 SERIES PORTABLE RESUSCITATION SYST. LIFE SCIENCE INSTRUMENTATION, INC.
K812520 09/02/1981 280/4 MINI-DEFIBRILLATOR LIFE SCIENCE INSTRUMENTATION, INC.
K812642 09/16/1981 ENGSTROM ERICA LKB INSTRUMENTS, INC.
K812531 09/02/1981 CELL CULTURE REAGENTS M.A. BIOPRODUCTS
K812734 09/29/1981 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P MACHIDA AMERICA, INC.
K812654 09/17/1981 VELCRO FINGER/TOE SPLINT MADDAK, INC.
K812655 09/17/1981 VELCRO SPLINT STRAP FASTENERS MADDAK, INC.
K812532 09/02/1981 TEMP-FILL MADRID USO, JR., D.D.S.
K812690 09/22/1981 C-PEPTIDE CONTROL PACK MALLINCKRODT CRITICAL CARE
K812689 09/22/1981 RIA QUANT C-PEPTIDE KIT MALLINCKRODT CRITICAL CARE
K812543 09/04/1981 TANARAMA MARKETING CONSULTANTS OF AMERICA
K812603 09/15/1981 TANARAMA MARKETING CONSULTANTS OF AMERICA
K812560 09/08/1981 MDM ARTERIAL BLOOD GAS SYRINGE MARTELL MEDICAL PRODUCTS, INC.
K812608 09/15/1981 VASCULAB #R12B MEDASONICS, INC.
K812609 09/15/1981 VASCULAB #VSC21 MEDASONICS, INC.
K812555 09/08/1981 DISPOSABLE SUTURE REMOVAL SCISSORS MEDCARE PRODUCTS
K812694 09/22/1981 WHISK-R MEDI-SPEC
K812735 09/29/1981 CLOTH SURGICAL GLOVES MEDICAL SYNERGY
K812517 09/02/1981 CARDIAC PACING ELECTRODES MEDICS INSTRUMENT CORP.
K812713 09/25/1981 DRAWER TEST MEDMETRIC CORP.
K812709 09/24/1981 STERILE DENTAL ROLL MEDSPEC CORP.
K812707 09/24/1981 STERILE DISSECTOR SPONGES-X-RAY DETECT MEDSPEC CORP.
K812711 09/24/1981 STERILE GAUZE PADS 12PLY MEDSPEC CORP.
K812710 09/24/1981 STERILE LAPAROTOMY SPONGES-X-RAY DETECT MEDSPEC CORP.
K812599 09/14/1981 MEDTRONIC #4951 MEDTRONIC VASCULAR
K812580 09/10/1981 MEDTRONIC MODEL 2409 MEDTRONIC VASCULAR
K812725 09/28/1981 MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD MEDTRONIC VASCULAR
K812703 09/22/1981 MODEL 9408 A TELETRACE MEDTRONIC VASCULAR
K812704 09/23/1981 NEUROMED SELECTRA #7720 MEDTRONIC VASCULAR
K812529 09/02/1981 EARSCAN MICRO AUDIOMETRICS CORP.
K812753 09/29/1981 AMES TDA QUINIDINE TEST MILES LABORATORIES, INC.
K812518 09/02/1981 AMES TDA THEOPHYLLINE TEST MILES LABORATORIES, INC.
K812558 09/08/1981 TISSUE-TEK III ACCU-CUT ROTARY MICROTOME MILES LABORATORIES, INC.
K812692 09/22/1981 FILES & REAMERS MILTEX INSTRUMENT CO.
K812706 09/24/1981 MILLER/NADLER GLARE TESTER MOSEBACH ELECTRIC & SUPPLY
K812513 09/02/1981 MINI O2 MOUNTAIN MEDICAL EQUIPMENT, INC.
K812752 09/29/1981 MICRO MED INT'L MICRO SOUND US-100 N-TRON ELECTRONICS
K812588 09/11/1981 SCANNER 700 NATIONAL ULTRASOUND CORP.
K812516 09/02/1981 SURGICAL BLADES & SCAPELS (SMPL. W/510K) NEEDLE INDUSTRIES(USA), INC.
K812740 09/29/1981 REAGENTS FOR SERODIAGNOSIS OF ASPERGILL NOLAN BIOLOGICAL LABORATORIES, INC.
K812741 09/29/1981 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS NOLAN BIOLOGICAL LABORATORIES, INC.
K812737 09/29/1981 RAIN-X NOVA-VENTRX
K812701 09/23/1981 ORTHO-THERM INFRARED SENSOR ORTHION CORP.
K812566 09/09/1981 UNIVERSAL SUTURE PASSER ORTHO PARED INSTRUMENTS, INC.
K812624 09/15/1981 OXEQUIP CONDUCTIVE & NON ANES. BREATH OXEQUIP HEALTH IND.
K812658 09/18/1981 CEA CONTROL PLASMA PACIFIC HEMOSTASIS
K812505 09/01/1981 PALL ULTIPOR VACUUM LINE BACTERIA FITLER PALL BIOMEDICAL PRODUCTS CO.
K812666 09/21/1981 THYROXINE (T4) 125I PCL-RIA, INC.
K812618 09/15/1981 ASSURE NATURAL FIT TAMPON PERSONAL PRODUCTS CO.
K812681 09/22/1981 ADULT FLEX FLOAT W/HEATER PHARMAQUEST CORP.
K812684 09/22/1981 ADULT FLEXFLOAT PHARMAQUEST CORP.
K812682 09/22/1981 FLEXFLOAT HEATER PHARMAQUEST CORP.
K812683 09/22/1981 NEONATE FLEXFLOAT PHARMAQUEST CORP.
K812534 09/03/1981 IMPROVED PLAYTEX TAMPON PLAYTEX, INC.
K812699 09/22/1981 AMYLASE POINTE SCIENTIFIC, INC.
K812574 09/09/1981 HDL CHOLESTEROL REAGENT POINTE SCIENTIFIC, INC.
K812542 09/04/1981 POLAROID INSTANT ENDOCAMERA POLAROID CORP.
K812657 09/18/1981 INJECTION CAP, LUER LOCK PROCEDURE PRODUCTS, INC.
K812651 09/17/1981 X-RAY DETECTABLE LAP SPONGES PROCTER & GAMBLE MFG. CO.
K812744 09/29/1981 LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER PROGRESS MANKIND TECHNOLOGY
K812676 09/22/1981 AMPLITONE-3 PROGRESSIVE TECHNOLOGY, INC.
K812578 09/09/1981 ELEGANCE QUALITONE
K812718 09/25/1981 CUFF MATERIAL ON PEDIATRIC SIZE CATH. QUINTON, INC.
K812717 09/25/1981 NON-STERILE SHADOW-STRIPE CATHETER QUINTON, INC.
K812688 09/22/1981 QI 1150-1T INFUSION T QUINTON, INC.
K812607 09/15/1981 TENCKHOFF PERITONEAL CATHETERS QUINTON, INC.
K812641 09/16/1981 URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM REAGENTS APPLICATIONS, INC.
K812698 09/22/1981 GC DISK REMEL CO.
K812503 09/01/1981 BOSCH HEARING INSTRUMENTS RETLIF, INC.
K812670 09/21/1981 SANDARE FAST 340 PHOSPHORUS PROCEDURE SANDARE CHEMICAL CO., INC.
K812547 09/04/1981 "BEAUBON" SCI-PHARM, INC.
K812550 09/04/1981 "BEAUCAV" SCI-PHARM, INC.
K812551 09/04/1981 "BEAUCOR" SCI-PHARM, INC.
K812546 09/04/1981 "BEAUDENT" SCI-PHARM, INC.
K812545 09/04/1981 "BEAUFILL" SCI-PHARM, INC.
K812549 09/04/1981 "BEAUSEAL" SCI-PHARM, INC.
K812548 09/04/1981 "COBEAU" SCI-PHARM, INC.
K812747 09/29/1981 ARGYLE SUCTION CATHETERS SHERWOOD MEDICAL CO.
K812570 09/09/1981 LABCER FIBRINOGEN ASSAY KIT & CALIBR. SHERWOOD MEDICAL CO.
K812748 09/29/1981 MONOJECT M535 35CC SYRINGE SHERWOOD MEDICAL CO.
K812569 09/09/1981 SHERWOOD WATER TRAP SHERWOOD MEDICAL CO.
K812742 09/29/1981 SHILEY ARTERIAL FILTER W/40 MICRON SCREE SHILEY, INC.
K812721 09/28/1981 DIGITRON SIEMENS CORP.
K812616 09/15/1981 POLYPHOS 500 SIEMENS CORP.
K812610 09/15/1981 SIEMENS-ELEMA PULSE GENERATOR 668 B SIEMENS CORP.
K812646 09/17/1981 SKI 5000 SMITH KLINE DIAGNOSTICS, INC.
K812720 09/25/1981 BODAI PATIENT COMMUNICATOR SONTEK INDUSTRIES, INC.
K812757 09/30/1981 SORENSON THERMODILUTION CARDIAC COMPUT SORENSEN RESEARCH
K812691 09/22/1981 SILICONE IMPLANTS SUTTER BIOMEDICAL, INC.
K812647 09/17/1981 EMIT AUTO CAROUSEL SYVA CO.
K812579 09/10/1981 SUNTANNING HOME UNIT TANNHUT
K812715 09/25/1981 TECA #TE 8 TECA, INC.
K812663 09/18/1981 SOLARIUM COMBINATION TECH-PRO, INC.
K812743 09/29/1981 FETAL VITABILITY TM MODE TECHNICARE CORP.
K812660 09/18/1981 TERUMO HOLLOW FIBER OXYGENATOR TERUMO MEDICAL CORP.
K812659 09/18/1981 TERUMO HOLLOW OXYGENATOR CIRCUIT TERUMO MEDICAL CORP.
K812738 09/29/1981 BOUNDARY PROCESS CHANGE THE BUCKEYE CELLULOSE CORP.
K812736 09/29/1981 SOFTCARE BARRIER WET DRESSING THE KENDAL CO.
K812552 09/04/1981 COROMETRICS MEDICAL SYST. 220 PH ANALY. TRANSIDYNE GENERAL CORP.
K812601 09/14/1981 SQC BUFFER TRANSIDYNE GENERAL CORP.
K812510 09/02/1981 TRAVENOL INFUSION CONTROLLER 2M8052 TRAVENOL LABORATORIES, S.A.
K812615 09/15/1981 TM-CAPD TRI-MED, INC.
K812527 09/02/1981 IVA SEAL II U.S. CLINICAL PRODUCTS, INC.
K812536 09/03/1981 LINDE MARK II UNION CARBIDE CORP.
K812640 09/16/1981 URE SIL EMBOLECTOMY/THROMBECTOMY CATH URESIL CORP.
K812581 09/10/1981 SENSI-TECT UTI-TECT, INC.
K812605 09/15/1981 FIBER OPTIC LIGHT SOURCE I VENTURE TECHNOLOGY, INC.
K812723 09/28/1981 PEARCE CORNEAL TREPHINE VISITEC CO.
K812739 09/29/1981 VITALOG PMS-8 MONITOR VITALOG CORP.
K812620 09/15/1981 ADJUSTABLE MICROSURGICAL KNIFE VXTRA CORP.
K812526 09/02/1981 MICRO BLADE II VXTRA CORP.
K812577 09/09/1981 UNSCENTED MENSTRUAL PADS WEYERHAEUSER CO.
K812572 09/09/1981 GAUZE SPONGES WORLDWIDE SURGICAL GAUZE
K812564 09/08/1981 ZEE LIFE SUPPORT AIR PANTS ZEE MEDICAL PRODUCTS CO., INC.


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