FDA 510(k) Decisions During October, 1981  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K812697 10/08/1981 HEMA 20 MICRON TRANSFUSION BLOOD FILTER ABBOTT LABORATORIES
K812848 10/23/1981 ACCRA LAB HEMOTOLOGY ACCRA LABORATORIES, INC.
K810592 10/23/1981 NUCLEAR ANTIGENS ALPHA ANTIGENS, INC.
K812637 10/26/1981 ACMI BIPOLAR HEMOSTATIC SOURCE AMERICAN CYSTOCOPE MAKERS, INC.
K812424 10/02/1981 CI-TROL HEPARIN CONTROLS, LOW/HIGH AMERICAN DADE
K812892 10/27/1981 S/P SERUM DROPPER PIPETS AMERICAN DADE
K812695 10/13/1981 DISK AMERICAN HEARTLINE, INC.
K811916 10/14/1981 OPERATING ROOM KIT AMERICAN HOSPITAL SUPPLY CORP.
K812282 10/23/1981 PORTABLE OXYGEN GENERATOR AMERICAN MARKETING ASSOC., INC.
K812862 10/26/1981 API GERM TUBE ANALYTAB PRODUCTS, INC.
K812877 10/26/1981 PENASE ANALYTAB PRODUCTS, INC.
K812836 10/09/1981 LDH REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K812835 10/09/1981 TOTAL CALCIUM REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K812749 10/19/1981 ULTRA-DIG ANTIBODIES INC.
K812881 10/26/1981 IMMUNEX CRP ARMKEL, LLC.
K812882 10/26/1981 RHEUMATEX ARMKEL, LLC.
K812719 10/06/1981 PROSANA BELT BANDWAGON, INC.
K812571 10/06/1981 MEZLOCILLIN 75 MCG. SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812286 10/02/1981 MINITECK ENTERIC BROTH & ENTEROBACTER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812844 10/23/1981 MOXALACTAM 30MCG. SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812784 10/20/1981 BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD BECKMAN INSTRUMENTS, INC.
K812754 10/19/1981 BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN BECKMAN INSTRUMENTS, INC.
K812649 10/19/1981 BECKMAN ICS CALIBRATOR BECKMAN INSTRUMENTS, INC.
K812650 10/19/1981 BECKMAN ICS NORMAL CONTROL SERA BECKMAN INSTRUMENTS, INC.
K812619 10/08/1981 ISOLATED VOLTAGE/FREQUENCY CONVERTER BIO-FEEDBACK SYSTEMS, INC.
K812677 10/02/1981 UNITEST-POTASSIUM BIODYNAMICS CORP.
K812565 10/23/1981 ELUTION SOLUTION BIOLOGICAL CORP. OF AMERICA
K812530 10/13/1981 TRANSDUCER DOME BIOMEAL CORP.
K811737 10/14/1981 BIO-TONE MODEL 4 BIOTONE INTERNATIONAL, INC.
K812825 10/26/1981 FLO-COR I BIOTRINE CORP.
K812218 10/13/1981 KALOS-03 BIOTRONIK SALES, INC.
K812604 10/02/1981 BIOVATION URINALYSIS REPORTER BIOVATION, INC.
K812304 10/13/1981 DORROS-SPRING PRESSURIZER CARDIOVASCULAR DIAGNOSTIC SERVICES
K812441 10/06/1981 DI-CROWN COBURN OPTICAL IND., INC.
K812617 10/02/1981 VITROGEN TM 100 COLLAGEN CORP.
K812358 10/29/1981 MODEL 325T PROGRAMMABLE PULSE GENERATOR COOK PACEMAKER CORP.
K812781 10/29/1981 TEMPORARY PERVENOUS J-ATRIAL LEAD CORDIS CORP.
K812786 10/23/1981 FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS CORNING MEDICAL & SCIENTIFIC
K812672 10/08/1981 SELF-CENTERING HIP DEPUY, INC.
K812281 10/13/1981 TOUCHLESS HOME-CATH DIAMED DIVISION ILL. TOOL WORKS, INC.
K812515 10/02/1981 CARDIAC REVIEW STATION DIASONICS, INC.
K812525 10/02/1981 MEZLOCILLIN 75 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K812228 10/28/1981 MOXALACTAM 30 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K812799 10/20/1981 "DCATS" DOREX, INC.
K812772 10/19/1981 PERITONEAL DIALYSIS CYCLER SET (8UNIT) DRAVON MEDICAL, INC.
K812771 10/19/1981 PERITONEAL DIALYSIS DRAINAGE DRAVON MEDICAL, INC.
K812664 10/02/1981 "ACA" IMMUNOGLOBULIN G ANALYTICAL TEST E.I. DUPONT DE NEMOURS & CO., INC.
K812627 10/08/1981 ACA ANTITHROMBIN III TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812629 10/08/1981 ACA FIBRINOGEN TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812535 10/19/1981 PLASTILIX MINIRAD D CASSETTE EASTMAN KODAK COMPANY
K812606 10/13/1981 SECTORTAC ECHO LABORATORIES, INC.
K812020 10/20/1981 EGNELL COMPACT, TYPE EHV EGNELL, INC.
K812674 10/13/1981 INFANT CARIDAC MONITOR ELECTROMED INTL., LTD.
K812292 10/23/1981 AUTOTRANS BT795 ELECTROMEDICS, INC.
K812758 10/20/1981 PHYSIOLOGICAL PRESSURE TRANSDUCER ELECTROMEDICS, INC.
K812455 10/23/1981 SUCKER CARDIOTOMY RETURN, C.P. BYPASS ELECTROMEDICS, INC.
K812635 10/02/1981 ANEMIA CONTROL ENVIRONMENTAL CHEMICAL SPECIALTIES
K812818 10/23/1981 TITERTEK AUTODROP FLOW LABORATORIES, INC.
K812826 10/23/1981 FORMA CH/P GAS PROCESSOR FORMA SCIENTIFIC, INC.
K812639 10/02/1981 UNICUFF FRONTIER PRODUCTS
K812406 10/06/1981 EXAFLEX IMPRESSION MATERIAL G-C INTL. CORP.
K812679 10/06/1981 G-C FIT-CHECKER IMPRESSION MATERIAL G-C INTL. CORP.
K812680 10/06/1981 G-C IMPRESSION SYRINGE G-C INTL. CORP.
K812539 10/13/1981 PRE-BYPASS FILTER GELMAN SCIENCES, INC.
K812783 10/23/1981 TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK GENERAL DIAGNOSTICS
K812509 10/13/1981 CT/T 8800 GENERAL ELECTRIC CO.
K812561 10/13/1981 LATERAL ANGULATING FLUORO SUSPENSION SYS GENERAL ELECTRIC CO.
K812861 10/23/1981 CHOLESTEROL CALIBRATORS GILFORD DIAGNOSTICS
K812594 10/02/1981 ULTRA ZYME PLUS AMYL #64982 & 65031 HARLECO
K812593 10/02/1981 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 HARLECO
K812428 10/23/1981 HELENA COLOSCREEN METHOD HELENA LABORATORIES
K812687 10/02/1981 BRIGHAM II TOTAL HIP SYSTEM HEXCEL MEDICAL
K812669 10/02/1981 SEATTLE II TOTAL HIP SYSTEM HEXCEL MEDICAL
K812731 10/19/1981 SEPTI-CHECK BLOOD CULTURE SLIDE HOFFMANN-LA ROCHE, INC.
K812732 10/19/1981 SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE HOFFMANN-LA ROCHE, INC.
K812729 10/19/1981 SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE HOFFMANN-LA ROCHE, INC.
K812730 10/23/1981 SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE HOFFMANN-LA ROCHE, INC.
K812667 10/23/1981 MEDDARS/ULTRA IMAGER RESPIRATION MODULE HONEYWELL, INC.
K812575 10/19/1981 MODEL H12-10 HOSPAL MEDICAL CORP.
K812763 10/20/1981 ECG MEDATAPE-601 HOSPITAL EQUIPMENT SERVICE
K812774 10/23/1981 VENTILATOR CIRCUIT HUDSON OXYGEN THERAPY SALES CO.
K812562 10/02/1981 SURGICAL RETRACTOR & ELASTIC STAYS, DISP HUMBOLDT PRODUCTS
K812597 10/19/1981 FERRITIN KIT HYBRITECH, INC.
K812461 10/13/1981 TANDEM QUALITATIVE HCG KIT HYBRITECH, INC.
K812405 10/20/1981 STERILE TV CAMERA & CORD COVER HYDRO-MED PRODUCTS, INC.
K812773 10/23/1981 BENNETT VOLUME VENTILATOR CIRCUIT IDEAL MEDICAL, INC.
K812823 10/27/1981 IMED MODEL 970 & 975 VOL. INFUSION PUMP IMED CORP.
K812824 10/27/1981 PRESSURE DISC COMPONENT FOR ACCUSET IMED CORP.
K812821 10/26/1981 H-103 IGG, H-104 IGA, H-105 IGM IMMULOK, INC.
K812321 10/29/1981 HYDROXI-FLEX IMPLANT IMPLADENT
K812859 10/26/1981 IDS PORPHYRIN REAGENT INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
K812762 10/20/1981 IL 501, NA/K ANALYZER INSTRUMENTATION LABORATORY CO.
K812872 10/26/1981 OPTIONAL TOTAL CA-MODULE FOR IL 504/508 INSTRUMENTATION LABORATORY CO.
K812756 10/29/1981 ADAPTAID #365-38 INTERMEDICS, INC.
K812502 10/13/1981 IMPLANTAID LEAD INTRODUCER #319-10 & 12 INTERMEDICS, INC.
K812812 10/27/1981 INTERMEDICS ADAPTAID STEP-DOWN ADAPTER INTERMEDICS, INC.
K812245 10/06/1981 INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL INTERMEDICS, INC.
K812221 10/06/1981 INTERMEDICS POLY FLEX EPICARDIAL SUTURE INTERMEDICS, INC.
K812813 10/27/1981 INTERMEDICS PROGRAMMER, MODEL 522-03 INTERMEDICS, INC.
K812671 10/02/1981 EMBRITROL CK-MB CONTROLS INTL. IMMUNOASSAY LABORATORIES, INC.
K812675 10/13/1981 DISPOSABLE SURGICAL FACE MASKS IREMA USA LTD.
K812795 10/20/1981 ANAEROBIC BLOOD AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K812796 10/20/1981 ANAEROBIC CNA BLOOD AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K812798 10/20/1981 MOTILITY GI MEDIUM ISLE MEDIA AND STERILE PRODUCTS, INC.
K812797 10/20/1981 SCHAEDLER AGARS ISLE MEDIA AND STERILE PRODUCTS, INC.
K811867 10/02/1981 SR-ALGICAP J. ADERER, INC.
K812746 10/26/1981 THORACIC DRAINAGE SET #55-DB2-G J. H. EMERSON CO.
K812573 10/23/1981 SPIROMETER FILTER K & G HEALTHCARE IND., INC.
K812611 10/02/1981 QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO KALLESTAD LABORATORIES, INC.
K812587 10/06/1981 MONO 2 OXYGEN MONITOR KANTRON CARDIOVASCULAR, INC.
K812644 10/26/1981 REPLACEABLE BATTERY PERFECTEMP 2" CAUT KEY MEDICAL, INC.
K812521 10/02/1981 SUNTANNING DEVICE (SEPAR. FROM K812225) KLAFS SUNLIGHT CORP.
K812656 10/08/1981 DOTRICH ELECTRONIC AIR CLEANER #C500AM LEEDAL, INC.
K812693 10/13/1981 LIF-O-GEN #3000 OXYGEN CONCENTRATOR LIF-O-GEN, INC.
K812019 10/02/1981 LOXLEY EMERGENCY CERVICAL COLLAR LOXLEY MEDICAL
K812531 10/23/1981 CELL CULTURE REAGENTS M.A. BIOPRODUCTS
K812734 10/19/1981 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P MACHIDA AMERICA, INC.
K812532 10/14/1981 TEMP-FILL MADRID USO, JR., D.D.S.
K812690 10/06/1981 C-PEPTIDE CONTROL PACK MALLINCKRODT CRITICAL CARE
K812689 10/06/1981 RIA QUANT C-PEPTIDE KIT MALLINCKRODT CRITICAL CARE
K812543 10/08/1981 TANARAMA MARKETING CONSULTANTS OF AMERICA
K812560 10/09/1981 MDM ARTERIAL BLOOD GAS SYRINGE MARTELL MEDICAL PRODUCTS, INC.
K812608 10/02/1981 VASCULAB #R12B MEDASONICS, INC.
K812609 10/02/1981 VASCULAB #VSC21 MEDASONICS, INC.
K812426 10/08/1981 UTERINE ASPIRATION CURETTES(RIGID&FLEX) MEDI-SPEC
K812694 10/26/1981 WHISK-R MEDI-SPEC
K812124 10/02/1981 MLA ELECTRA 700 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
K812517 10/13/1981 CARDIAC PACING ELECTRODES MEDICS INSTRUMENT CORP.
K812709 10/23/1981 STERILE DENTAL ROLL MEDSPEC CORP.
K812599 10/23/1981 MEDTRONIC #4951 MEDTRONIC VASCULAR
K812155 10/08/1981 MEDTRONIC DUAL CHANNEL SPINAL CORD STIM MEDTRONIC VASCULAR
K812703 10/23/1981 MODEL 9408 A TELETRACE MEDTRONIC VASCULAR
K812704 10/19/1981 NEUROMED SELECTRA #7720 MEDTRONIC VASCULAR
K810338 10/20/1981 LYMPHA PRESS MEGO AFEK
K812529 10/14/1981 EARSCAN MICRO AUDIOMETRICS CORP.
K812753 10/19/1981 AMES TDA QUINIDINE TEST MILES LABORATORIES, INC.
K812692 10/23/1981 FILES & REAMERS MILTEX INSTRUMENT CO.
K812588 10/19/1981 SCANNER 700 NATIONAL ULTRASOUND CORP.
K812516 10/02/1981 SURGICAL BLADES & SCAPELS (SMPL. W/510K) NEEDLE INDUSTRIES(USA), INC.
K812740 10/20/1981 REAGENTS FOR SERODIAGNOSIS OF ASPERGILL NOLAN BIOLOGICAL LABORATORIES, INC.
K812741 10/23/1981 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS NOLAN BIOLOGICAL LABORATORIES, INC.
K812737 10/23/1981 RAIN-X NOVA-VENTRX
K812759 10/19/1981 NML CK-MB RIA NUCLEAR MEDICAL LABORATORIES, INC.
K811951 10/16/1981 DRESSING CHANGE TRAYS & STERILE SPONGES O.R. SPECIALTIES, INC.
K812393 10/13/1981 4001 CT SCANNER OMNIMEDICAL
K812400 10/02/1981 OMNIMEDICAL QUAD I OMNIMEDICAL
K812701 10/13/1981 ORTHO-THERM INFRARED SENSOR ORTHION CORP.
K811713 10/23/1981 AVI-D CONTROL ORTHO DIAGNOSTIC SYSTEMS, INC.
K812002 10/28/1981 ELUAID ORTHO DIAGNOSTIC SYSTEMS, INC.
K812801 10/20/1981 HIP STEM SYSTEM TITANIUM ALLOY OSTEONICS CORP.
K812624 10/26/1981 OXEQUIP CONDUCTIVE & NON ANES. BREATH OXEQUIP HEALTH IND.
K812815 10/29/1981 MODEL 833 ENDOCARDIAL TINED LEAD PACESETTER SYSTEMS
K812816 10/29/1981 MODEL 841 ENDOCARDIAL TINED LEAD PACESETTER SYSTEMS
K812666 10/02/1981 THYROXINE (T4) 125I PCL-RIA, INC.
K812618 10/02/1981 ASSURE NATURAL FIT TAMPON PERSONAL PRODUCTS CO.
K812782 10/23/1981 DISPENSER ASPIRATOR DA 300 PHARMACIA, INC.
K812681 10/08/1981 ADULT FLEX FLOAT W/HEATER PHARMAQUEST CORP.
K812684 10/08/1981 ADULT FLEXFLOAT PHARMAQUEST CORP.
K812682 10/08/1981 FLEXFLOAT HEATER PHARMAQUEST CORP.
K812683 10/13/1981 NEONATE FLEXFLOAT PHARMAQUEST CORP.
K812870 10/29/1981 IMPROVED PLAYTEX TAMPON PLAYTEX, INC.
K812699 10/06/1981 AMYLASE POINTE SCIENTIFIC, INC.
K812794 10/20/1981 LIPASE POINTE SCIENTIFIC, INC.
K812542 10/19/1981 POLAROID INSTANT ENDOCAMERA POLAROID CORP.
K812657 10/23/1981 INJECTION CAP, LUER LOCK PROCEDURE PRODUCTS, INC.
K812651 10/20/1981 X-RAY DETECTABLE LAP SPONGES PROCTER & GAMBLE MFG. CO.
K812676 10/13/1981 AMPLITONE-3 PROGRESSIVE TECHNOLOGY, INC.
K812578 10/02/1981 ELEGANCE QUALITONE
K812718 10/19/1981 CUFF MATERIAL ON PEDIATRIC SIZE CATH. QUINTON, INC.
K812717 10/19/1981 NON-STERILE SHADOW-STRIPE CATHETER QUINTON, INC.
K812688 10/02/1981 QI 1150-1T INFUSION T QUINTON, INC.
K812607 10/02/1981 TENCKHOFF PERITONEAL CATHETERS QUINTON, INC.
K812641 10/02/1981 URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM REAGENTS APPLICATIONS, INC.
K812698 10/06/1981 GC DISK REMEL CO.
K812203 10/13/1981 ELECTROSURGICAL UNIT REZNIK INSTRUMENTS
K812205 10/26/1981 FORCEP REZNIK INSTRUMENTS
K812206 10/13/1981 LAPAROSCOPE REZNIK INSTRUMENTS
K812201 10/19/1981 PHOTOGRAPHIC EQUIPMENT REZNIK INSTRUMENTS
K812199 10/13/1981 TROCAR & TROCAR SLEEVES REZNIK INSTRUMENTS
K812204 10/13/1981 UTERINE MANIPULATORS REZNIK INSTRUMENTS
K812846 10/29/1981 CLEAR-RITE II RICHARD-ALLAN MEDICAL IND., INC.
K812847 10/29/1981 XYLENE RICHARD-ALLAN MEDICAL IND., INC.
K812670 10/02/1981 SANDARE FAST 340 PHOSPHORUS PROCEDURE SANDARE CHEMICAL CO., INC.
K812501 10/02/1981 OPRAFLEX SELOMAS, INC.
K812747 10/23/1981 ARGYLE SUCTION CATHETERS SHERWOOD MEDICAL CO.
K812570 10/02/1981 LABCER FIBRINOGEN ASSAY KIT & CALIBR. SHERWOOD MEDICAL CO.
K812748 10/23/1981 MONOJECT M535 35CC SYRINGE SHERWOOD MEDICAL CO.
K812616 10/13/1981 POLYPHOS 500 SIEMENS CORP.
K812860 10/26/1981 IMMUNOASSAY PLATE SKATRON, INC.
K812256 10/20/1981 MODEL AP 180 MINI-MONITOR SONICAID, INC.
K812800 10/20/1981 FLOW-DIRECTED THERMODILUTION CATHETER SORENSEN RESEARCH
K812052 10/06/1981 MYOCATH CATOLOG NO. MCK-A SORENSEN RESEARCH
K802342 10/14/1981 PROXIMAL INTERPHALANGEAL JOINT IMPLANT SUTTER BIOMEDICAL, INC.
K812647 10/02/1981 EMIT AUTO CAROUSEL SYVA CO.
K812579 10/08/1981 SUNTANNING HOME UNIT TANNHUT
K812715 10/13/1981 TECA #TE 8 TECA, INC.
K812663 10/29/1981 SOLARIUM COMBINATION TECH-PRO, INC.
K812410 10/02/1981 DELTASCAN 2060 CT SCANNER TECHNICARE CORP.
K811593 10/13/1981 ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J TELECTRONICS, INC.
K812790 10/29/1981 IMPLANTABLE VENTRICULAR-INHIBITED CARDI TELECTRONICS, INC.
K812337 10/02/1981 ISOCENTRIC NEUTRON THERAPY SYSTEMS THE CYCLOTRON CORP.
K812777 10/19/1981 DIRECT IRON REAGENT SET THE DOW CHEMICAL CO.
K812446 10/13/1981 SUNLAMP THE RICHMOND LIGHT CO.
K812779 10/26/1981 EXTENSIONS-LUSATZTISCH THE TELOS CO.
K812176 10/05/1981 KORICLEAN TRANS WORLD AGENCY, INC.
K812601 10/02/1981 SQC BUFFER TRANSIDYNE GENERAL CORP.
K812448 10/02/1981 UNI-THANE UNICARE SYSTEMS, INC.
K812640 10/02/1981 URE SIL EMBOLECTOMY/THROMBECTOMY CATH URESIL CORP.
K812605 10/02/1981 FIBER OPTIC LIGHT SOURCE I VENTURE TECHNOLOGY, INC.
K812723 10/13/1981 PEARCE CORNEAL TREPHINE VISITEC CO.
K812620 10/19/1981 ADJUSTABLE MICROSURGICAL KNIFE VXTRA CORP.
K812073 10/06/1981 DESERET CATHETER DRESSING WARNER-LAMBERT CO.
K812577 10/19/1981 UNSCENTED MENSTRUAL PADS WEYERHAEUSER CO.
K812564 10/23/1981 ZEE LIFE SUPPORT AIR PANTS ZEE MEDICAL PRODUCTS CO., INC.


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