FDA 510(k) Applications Received During September, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781556 09/11/1978 PRESSURE INFUSION CUFF ABBOTT LABORATORIES
K781581 09/15/1978 SURGICAL LIGHT 22" SERIES AMERICAN STERILIZER CO.
K781667 09/25/1978 AMPLAID MARK 4 AND MARK 5 AMPLAID USA, INC.
K781604 09/18/1978 CDC ANAEROBE BLOOD AGAR ANAEROBE SYSTEMS
K781603 09/18/1978 CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH. ANAEROBE SYSTEMS
K781602 09/18/1978 CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM. ANAEROBE SYSTEMS
K781567 09/14/1978 API ZYM ANALYTICAL PRODUCTS, INC.
K781651 09/27/1978 HEALTH POINT ANRITSU AMERICA CO.
K781654 09/27/1978 NEPHELRATE ANTIPERUMS LGM ANTIBODIES INC.
K781655 09/27/1978 NEPHELRATE ANTISERUMS 1GA ANTIBODIES INC.
K781653 09/27/1978 NEPHELRATE ANTISERUMS C3C ANTIBODIES INC.
K781656 09/27/1978 NEPHELRATE ANTISERUMS, IGG ANTIBODIES INC.
K781658 09/28/1978 PROJECTOR, ACCU-CHART ACUITY BAUSCH & LOMB, INC.
K781662 09/28/1978 RIA, T3 UPTAKE SOLID PHASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781643 09/25/1978 ACID FAST KIT BIOSCIENTIFIC
K781584 09/18/1978 GRAM STAIN KIT BIOSCIENTIFIC
K781587 09/18/1978 HEMATOLOGY STAIN PACK BIOSCIENTIFIC
K781585 09/18/1978 HEMATOXYLIN STAIN "HARRIS" BIOSCIENTIFIC
K781582 09/18/1978 PAPANICOLAOU STAIN "EA-36" BIOSCIENTIFIC
K781583 09/18/1978 PAPANICOLAOU STAIN :EA-50: BIOSCIENTIFIC
K781588 09/18/1978 PAPANICOLAOU STIAN "OG-6" BIOSCIENTIFIC
K781644 09/25/1978 ANTIBIOTIC NEPHELOMETER BIOVATION, INC.
K781538 09/08/1978 SINGLE VIAL LDH-L TRIS BOEHRINGER MANNHEIM CORP.
K781632 09/25/1978 UROTRON BOEHRINGER MANNHEIM CORP.
K781661 09/29/1978 THERMOMETER, DIGITAL ELEC. MODEL 4755 BRITISH AEROSPACE, INC.
K781607 09/18/1978 STREP-TEX BURROUGHS WELLCOME CO.
K781577 09/15/1978 DISPOSABLE CARDIOTOMY; H-700F, H-700 C.R. BARD, INC.
K781527 09/05/1978 RIA SYSTEM FOR HUMAN FE-RITIN CALBIOCHEM-BEHRING CORP.
K781514 09/01/1978 ECG ELECTRODE, 2021, 2022, 2032, 2033 CARDIO-DYNAMICS LABORATORIES, INC.
K781541 09/08/1978 FLOMETER CHEMETRON MEDICAL PRODUCTS, INC.
K781542 09/08/1978 HEATED NEBULIZER CHEMETRON MEDICAL PRODUCTS, INC.
K781537 09/01/1978 NEBULIZER/HUMIDIFIER CHEMETRON MEDICAL PRODUCTS, INC.
K781650 09/27/1978 TERRY KERATOMETER CLIFFORD M. TERRY, M.C.
K781579 09/15/1978 MODIFIED STERILE DISPOSABLE STOPCOCKS COBE LABORATORIES, INC.
K781558 09/11/1978 PRESSURE MONITORING INJECTION LINES COBE LABORATORIES, INC.
K781507 09/01/1978 RETINOMETER COBURN OPTICAL IND., INC.
K781534 09/06/1978 SURG-O-PAK PREP PAD CONVERTORS
K781528 09/05/1978 COULTER ELECTROLYTE ANALYZER SYSTEM COULTER ELECTRONICS, INC.
K781628 09/25/1978 HEMO-W SYSTEM COULTER ELECTRONICS, INC.
K781576 09/15/1978 MINI-KEM COULTER ELECTRONICS, INC.
K781521 09/05/1978 CUTTER RESIFLEX URINE METER CUTTER LABORATORIES, INC.
K781668 09/28/1978 GAMMA RADIATION STERILIZATION PRECEDURE CUTTER LABORATORIES, INC.
K781593 09/18/1978 RIA CONTROLS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781595 09/15/1978 BODY-WORN HEARING AID, MODEL 787PP DANAVOX, INC.
K781596 09/15/1978 HEARING AID, MODEL 775 PP/AGC DANAVOX, INC.
K781600 09/18/1978 MISTY-OX PREFILLED HUMIDIFIER, DISP. DAVCO
K781642 09/21/1978 RA-I DIASONICS, INC.
K781664 09/28/1978 SILASTIC NEPHROSTOMY SYSTEM DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K781526 09/05/1978 SILASTIC U-TUBE KIT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K781645 09/25/1978 AUTODILUTER 2 DYNATECH LABORATORIES, INC.
K781646 09/25/1978 SRD-2 DYNATECH LABORATORIES, INC.
K781536 09/06/1978 VAC-U-PAC KIDNEY CASSETTE E-Z-EM, INC.
K781659 09/28/1978 ASSAY SYSTEM, GAMMAFLO, AUTOMATED E. R. SQUIBB & SONS, INC.
K781660 09/28/1978 RIA, DIGOXIN E. R. SQUIBB & SONS, INC.
K781631 09/25/1978 ECHO-OIL ECHO LABORATORIES, INC.
K781649 09/26/1978 ULTRASONIC TRANSDUCERS ECHO LABORATORIES, INC.
K781535 09/06/1978 AC ADAPTER:MODELS 9525,9526,9527 EDWARDS LABORATORIES
K781519 09/01/1978 EMI SIMULATOR REMOTE CONTROL CONSOLE EMI MEDICAL, INC.
K781509 09/01/1978 ZEE-FRAME EQUILIBRATED BIO SYSTEMS, INC.
K781547 09/13/1978 MICROSURGURY VISIBILITY BACKGROUND ETHICON, INC.
K781522 09/05/1978 THE VISUAL SPEECH AID EXETER MEDICAL LABS, INC.
K781633 09/21/1978 ULTRAFILTRATION SCALE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K781634 09/22/1978 VISUALAX FARRALL INSTRUMENTS, INC.
K781609 09/19/1978 ALKALINE PHOSPHATASE IN SERUM FISHER SCIENTIFIC CO., LLC.
K781610 09/19/1978 BILIRUBIN DETERMINTAITON IN SERUM FISHER SCIENTIFIC CO., LLC.
K781611 09/19/1978 CHOLESTEROL DET. IN SERUM FISHER SCIENTIFIC CO., LLC.
K781508 09/01/1978 WATERPATH SCANNING OPTION G.D. SEARLE AND CO.
K781523 09/05/1978 PFT GASES GARDNER CRYOGENICS
K781630 09/25/1978 GE-700 INTRA ORAL X-RAY SYSTEM GENERAL ELECTRIC CO.
K781571 09/14/1978 L/U ARM-VASCULAR GENERAL ELECTRIC CO.
K781524 09/05/1978 MAXIRAY 125 TUBE UNIT GENERAL ELECTRIC CO.
K781590 09/18/1978 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K781675 09/29/1978 X-RAY COLLIMATOR GENERAL X-RAY, INC.
K781676 09/29/1978 X-RAY STAND, PORTABLE GENERAL X-RAY, INC.
K781530 09/06/1978 TEMPERATURE CONTROLLER MODEL 17000 HEALTHDYNE, INC.
K781592 09/18/1978 SURGICAL ASPIRATOR TIPS HENRY SCHEIN, INC.
K781548 09/12/1978 UMBILICAL CORD CLAMP HOLLISTER, INC.
K781608 09/18/1978 CENTRAL PEG TIBIAL COMPONENT HOWMEDICA CORP.
K781589 09/18/1978 VOLUMETRIC CONTROLLER MODEL 310 IMED CORP.
K781546 09/13/1978 DIRECT ESTRIOL RIA KIT IMMUNALYSIS CORPORATION
K781575 09/14/1978 DISPOSABLE LYMPHANGIOGRAM SET INSTRANETICS, INC.
K781525 09/05/1978 ENDOCARIDAL PACING LEAD UNIPOLAR 477 INTERMEDICS, INC.
K781569 09/14/1978 NERVE LOCATER/STIMULATOR INTERMEDICS, INC.
K781568 09/14/1978 PACEMAKER, MODEL 251-01 INTERMEDICS, INC.
K781570 09/14/1978 SUTURELESS MUOCARDINE PACING LEADS 471 INTERMEDICS, INC.
K781580 09/15/1978 PERFIT DENTAL RESTORATIVE COMPOSITE LOCITE CORP.
K781578 09/15/1978 RIA QUANT B-HCG TEST KIT MALLINCKRODT CRITICAL CARE
K781544 09/08/1978 EPPENDORF "PCP 6121" MARILYN L. AMICK
K781641 09/21/1978 SURGITEK DOUBLE "J" URETEROL STENT MEDICAL ENGINEERING CORP.
K781606 09/18/1978 MEPA-1 BLOOD ANALYZER MEDICO ELECTRONIC, INC.
K781549 09/12/1978 TOXELISA TEST KIT MICROBIOLOGICAL ASSOC.
K781591 09/18/1978 NEBULIZER/HUMIDIFIER MODEL EH 147B MISTOGEN EQUIPMENT CO.
K781559 09/11/1978 LIFTING CHAIR & LIFTING LAVATORY SEAT MOTOR RISER CHAIRS LTD.
K781614 09/11/1978 MOTOR RISER TOLIT LIFT MOTOR RISER CHAIRS LTD.
K781615 09/21/1978 NASOSTAT NASOSTAT, INC.
K781665 09/28/1978 TUBE, LEATHERMAN/IMBRUCE NATIONAL CATHETER CO. DIV. MALLINCKRODT
K781539 09/08/1978 ISO-CARE KIT NICE-PAK PRODUCTS, INC.
K781560 09/11/1978 RIA DIAG. TEST KIT FOR INDEXING THYROX. NUCLEAR DIAGNOSTICS, INC.
K781554 09/11/1978 RAD-291 ORGANON, INC.
K781573 09/14/1978 ABNORMAL HEMATOLOGY CONTROL UNASSAYED ORTHO DIAGNOSTICS, INC.
K781572 09/14/1978 NORMAL HEMATOLOGY CONTROL UNASSAYED ORTHO DIAGNOSTICS, INC.
K781638 09/21/1978 RUBINDEX*DIRECT SYSTEM ORTHO DIAGNOSTICS, INC.
K781663 09/28/1978 HEARING AID, ITE MODULAR MODEL I, II, V OTICON CORP.
K781545 09/12/1978 AIR POWERED DENTAL HANDPIECE PROMIDENT MFG., LTD.
K781636 09/22/1978 C.P.R. COUNTING PACER QUAL-TEC, INC.
K781622 09/20/1978 PACING LEAD ADAPTER MODEL ACS 16 R.E. BROWN CO., INC.
K781627 09/20/1978 PACING LEAD ADAPTER MODEL ADB 21 R.E. BROWN CO., INC.
K781626 09/20/1978 PACING LEAD ADAPTER, ACV 14, ACV 23 R.E. BROWN CO., INC.
K781624 09/20/1978 PACING LEAD MODEL BUS 860, BUS 890 R.E. BROWN CO., INC.
K781625 09/20/1978 PACING LEAD MODEL MVM 860, MVM 890 R.E. BROWN CO., INC.
K781619 09/20/1978 PACING LEAD MODELS SA, 350, SAM 500 R.E. BROWN CO., INC.
K781621 09/20/1978 PACING LEAD MODELS, MAM 1260 MAM 1290 R.E. BROWN CO., INC.
K781620 09/20/1978 PACING LEAD MODELS, MDM 1060, MDM 1090 R.E. BROWN CO., INC.
K781623 09/20/1978 PACING MODELS MUM 860, MUM 890 R.E. BROWN CO., INC.
K781594 09/15/1978 DENTAL WARM WATER IRRIGATING SYSTEM RAMA CORP.
K781605 09/18/1978 R&R ABSORBENT POINTS RANSOM AND RANDOLPH
K781574 09/18/1978 PLASTI-PORE SEPTAL BUTTON RICHARD'S MEDICAL EQUIP., INC.
K781557 09/11/1978 24-HOUR URINE COLLECTION COOLING WRAP SAGE PRODUCTS, INC.
K781639 09/21/1978 SHILEY CRICOTHYROTOMY TUBE SHILEY, INC.
K781540 09/08/1978 OPTI 110/12/50 HSG SIEMENS CORP.
K781531 09/06/1978 OPTIPLANIMAT SIEMENS CORP.
K781613 09/19/1978 SIREMAT SIEMENS CORP.
K781532 09/06/1978 UROSKOP A AND B SIEMENS CORP.
K781543 09/08/1978 ORBIOGRAPH SONOMETRICS SYSTEMS, INC.
K781552 09/12/1978 MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2 SORENSEN RESEARCH
K781553 09/12/1978 MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 SORENSEN RESEARCH
K781550 09/12/1978 TRAUMA DRAINAGE SET 72T-28TTC SORENSEN RESEARCH
K781551 09/12/1978 TRAUMA DRAINAGE SET 72T-32TTC SORENSEN RESEARCH
K781635 09/22/1978 CHLORIDE TEST SET, CAT.# 0210 STANBIO LABORATORY
K781565 09/13/1978 ELECTRICAL NERVE STIMULATOR MODEL 6035 STIMULATION TECHNOLOGY, INC.
K781601 09/18/1978 TEKNI-CAL STRECK LABORATORIES, INC.
K781647 09/27/1978 BACK TRAC TECH ENGINEERING, INC.
K781533 09/06/1978 SMA/GGT TECHNICON INSTRUMENTS CORP.
K781598 09/18/1978 TECHNICON AUTOSLIDE STAINING/PROCESSING TECHNICON INSTRUMENTS CORP.
K781597 09/15/1978 PM 2000 AUTOMATIC PATIENT CHAIR TIME MOTION SYSTEM CO.
K781616 09/20/1978 OMNI STIK UNITRON CORP.
K781513 09/01/1978 HEARING AID, UNITRON MODEL 960PL UNITRON INDUSTRIES, INC.
K781510 09/01/1978 DISPOSABLE LECTROSWITCH, MODEL E2503 VALLEYLAB, INC.
K781511 09/01/1978 LECTROSWITCH MODEL E2502B VALLEYLAB, INC.
K781637 09/21/1978 MODEL IV 1500 STANDARD BURETTE VALLEYLAB, INC.
K781562 09/11/1978 HEMACHECK VICKERS AMERICA MEDICAL CORP.
K781629 09/25/1978 SERI-SEP SERUM/PLASMA ISLOLATOR WAKO INTL., INC.
K781517 09/01/1978 AUTOMATIC BLOOD PRESSURE DEVICE WELCH ALLYN, INC.
K781599 09/18/1978 I-ESTRIOL TEST SET WIEN LABORATORIES, INC.
K781561 09/12/1978 ANGIOGRAPHIC GUIDE WIRE WILSON MEDICAL INSTRUMENTS CO.
K781529 09/05/1978 SEPTAL BUTTON XOMED, INC.
K781520 09/01/1978 RUBBER DAM HOLDER YOUNG DENTAL MANUFACTURING CO 1, LLC.


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