FDA 510(k) Decisions During November, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781504 11/22/1978 125I-ALDOSTERONE RIA DIAG. KIT ABBOTT LABORATORIES
K781770 11/15/1978 SKIN MARKING PEN ABCO DEALERS, INC.
K781841 11/08/1978 BAR, DISTRACTION ACE ORTHOPEDIC MANUFACTURING CO.
K781839 11/08/1978 BONE CLAMP, ACE EXTERNAL ACE ORTHOPEDIC MANUFACTURING CO.
K781840 11/08/1978 EXTERNAL ARTICULATION ACE ORTHOPEDIC MANUFACTURING CO.
K781672 11/08/1978 ACU-DOT ACU-DOT PHARMACEUTICAL INTL., INC.
K781765 11/22/1978 LDH REAGENT SYSTEM AMERICAN MONITOR CORP.
K781845 11/20/1978 CAMSCAN SYSTEM AMERICAN OPTICAL CORP.
K781698 11/03/1978 EXAMINER 10 AMERICAN STERILIZER CO.
K781667 11/03/1978 AMPLAID MARK 4 AND MARK 5 AMPLAID USA, INC.
K781856 11/22/1978 PLATE, LD PRESUMPTO ANAEROBE SYSTEMS
K781654 11/08/1978 NEPHELRATE ANTIPERUMS LGM ANTIBODIES INC.
K781655 11/08/1978 NEPHELRATE ANTISERUMS 1GA ANTIBODIES INC.
K781653 11/08/1978 NEPHELRATE ANTISERUMS C3C ANTIBODIES INC.
K781656 11/08/1978 NEPHELRATE ANTISERUMS, IGG ANTIBODIES INC.
K781847 11/03/1978 LATEX, IN-HOUSE COMPOUNDED ARBROOK MFG. CORP.
K781793 11/03/1978 FRAME, UNIVERSAL DAY B.G. ORTHOPEDIC CORP.
K781674 11/15/1978 MACRO-VUE TEST, GENTAMICIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781662 11/08/1978 RIA, T3 UPTAKE SOLID PHASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780573 11/07/1978 TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781842 11/08/1978 OXYGENATOR, BLOOD BOS-10 BENTLEY LABORATORIES, INC.
K781786 11/15/1978 QUANTICEL HHR # L500 AND L501 BHP DIAGNOSTIX, INC.
K781745 11/15/1978 QUANTICEL HHR, L531 AND L532 BHP DIAGNOSTIX, INC.
K781702 11/15/1978 CALIBRATOR, BOVINE SERUM BIO-REAGENTS & DIAGNOSTICS, INC.
K781838 11/21/1978 CALCULATOR, WITH CHARGER C.R. BARD, INC.
K781954 11/29/1978 CATHETER INTRODUCERS, ARTERISE C.R. BARD, INC.
K781736 11/03/1978 DISC, COLOPLAST PRE-OP STOMA C.R. BARD, INC.
K781911 11/30/1978 ECG ANALYZER, HIGH SPEED CARDIO-DYNAMICS LABORATORIES, INC.
K781932 11/29/1978 BLOOD PRESSURE RECORDER CARDIODYNE, INC.
K781833 11/14/1978 EXERCISER, AIR-EZE INCENTIVE CHESEBROUGH-POND'S U.S.A. CO.
K781807 11/22/1978 REAGENT, FIREFLY #395 CHRONO-LOG CORP.
K781507 11/15/1978 RETINOMETER COBURN OPTICAL IND., INC.
K781907 11/22/1978 EAR STOPPLES FOR NOISE ATTENTION CROWN DELTA CORP.
K781521 11/22/1978 CUTTER RESIFLEX URINE METER CUTTER LABORATORIES, INC.
K781668 11/03/1978 GAMMA RADIATION STERILIZATION PRECEDURE CUTTER LABORATORIES, INC.
K781480 11/08/1978 ANTITHROMBIN III ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781478 11/15/1978 PLASMINOGEN ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781881 11/15/1978 HEARING AID, MODEL 781 DANAVOX, INC.
K781671 11/16/1978 BLOOD PRESSURE CUFF COVER DAVID COTT CO.
K781754 11/08/1978 SPLINT, HOAKE INFLATABLE AIR DEPUY, INC.
K781791 11/08/1978 BOARD, DISPOSABLE CONTROL COUNT DEXIDE, INC.
K781759 11/27/1978 RESCAL DIEMOLDING CORP.
K781756 11/15/1978 SILASTIC H.P. TRAPEXIAL IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K780819 11/07/1978 GLYCOHEMOGLOBIN-SKREEN TEST KIT EPPENDORF-BRINKMANN, INC.
K781863 11/06/1978 DEVICE, FEMALE INCONTINENCE ESCHMANN BROS. & WALSH LTD.
K781670 11/07/1978 STIMULATOR, E.S.I. NEURO EVOLUTIONARY SYSTEMS, INC.
K781522 11/08/1978 THE VISUAL SPEECH AID EXETER MEDICAL LABS, INC.
K781740 11/22/1978 REAGENT, HDL FISHER SCIENTIFIC CO., LLC.
K781814 11/08/1978 SULFATE, FIBRIQUIK PROTAMINE GENERAL DIAGNOSTICS
K781571 11/27/1978 L/U ARM-VASCULAR GENERAL ELECTRIC CO.
K781773 11/22/1978 ALBUMIN REAGENT GILFORD DIAGNOSTICS
K781775 11/22/1978 LDH GILFORD DIAGNOSTICS
K781774 11/22/1978 TOTAL PROTEIN GILFORD DIAGNOSTICS
K781940 11/29/1978 EKG ELECTRODES, DISPOSABLE HAYES PRODUCTS, INC.
K781530 11/14/1978 TEMPERATURE CONTROLLER MODEL 17000 HEALTHDYNE, INC.
K781471 11/08/1978 PNEUMATIC VITRECTOMY CONTROL UNIT HELFGOTT MEDICAL INSTRUMENTS
K781891 11/15/1978 PIPETTES, PLASTIC DISPOSABLE HILLWOOD CORP.
K781768 11/14/1978 CATHETERS, H-H ATRIAL AND PERITONEAL HOLTER-HAUSNER INTL.
K781908 11/27/1978 BREATHING CIRCUIT PRODUCTS, ANESTHESIA HOSPITAK, INC.
K781843 11/03/1978 RECORDER, HOLTER ELECTROCARDIOGRAM HOVIK CORP.
K781837 11/15/1978 WOUND SPAN BRIDGE III HOWMEDICA CORP.
K781589 11/22/1978 VOLUMETRIC CONTROLLER MODEL 310 IMED CORP.
K781851 11/07/1978 HEMOGLOBIN, TESTING SYSTEM ISOLAB, INC.
K781866 11/15/1978 CANNULA CADDY KATENA PRODUCTS, INC.
K781689 11/15/1978 REFLECT IMPRESSION MATERIAL KERR CORPORATION (DANBURY)
K781433 11/03/1978 AKRON MALE EXTERNAL CATHETER LATEX IND., INC.
K781461 11/08/1978 MODEL 7320 VISUAL STIMULATOR LIFE-TECH INSTRUMENTS, INC.
K781476 11/15/1978 MULAR GOLD LEAF ELECTRODE MODEL 7501 LIFE-TECH INSTRUMENTS, INC.
K780340 11/27/1978 IMV SYSTEM LKB INSTRUMENTS, INC.
K781869 11/22/1978 DROPPER, CEPTI-SEAL KOH SOLUTION MARION LABORATORIES, INC.
K781868 11/22/1978 DROPPER, CEPTI-SEAL LAVTOPHENOL MARION LABORATORIES, INC.
K781700 11/03/1978 IONOTPHORETIC APPLICATOR MCGHAN MEDICAL CORP.
K781087 11/22/1978 MEDICAL GRADE SILICONE ELASTOMER TUBING MCGHAN MEDICAL CORP.
K781239 11/03/1978 MYO-STIM MED GENERAL
K781906 11/16/1978 BLOOD PRESSURE DEVICE, 400 SERIES MED-TEK CORP.
K781818 11/15/1978 LAPARATOMY SPONGE MEDEN MEDICAL SALES DIVISION
K781718 11/03/1978 ALP REAGENT SET, ALKALINE PHOSPHATASE MEDICAL ANALYSIS SYSTEMS, INC.
K781719 11/03/1978 CPK REAGENT SET, NAD REDUCTION MEDICAL ANALYSIS SYSTEMS, INC.
K781723 11/03/1978 GLUCOSE HEXOKINASE, AUTO K MEDICAL ANALYSIS SYSTEMS, INC.
K781720 11/03/1978 HBDH ENZYME KINETIC REAGENT SET MEDICAL ANALYSIS SYSTEMS, INC.
K781724 11/03/1978 NAD REDUCTION METHOD, LACTATE PYRIVATE MEDICAL ANALYSIS SYSTEMS, INC.
K781721 11/03/1978 REAGENT SET, CHOLESTEROL MEDICAL ANALYSIS SYSTEMS, INC.
K781726 11/03/1978 REAGENT SET, SGPT SERUM GLUTAMIC MEDICAL ANALYSIS SYSTEMS, INC.
K781722 11/03/1978 REAGENT SET, TOTAL PROTEIN MEDICAL ANALYSIS SYSTEMS, INC.
K781725 11/03/1978 REAGENT SET, U.V. ENZMATIC KINETIC, SGOT MEDICAL ANALYSIS SYSTEMS, INC.
K781829 11/22/1978 NEUROPAC ULTRA II MEDICAL DEVICES, INC.
K781924 11/22/1978 POUCHES AND TUBING, MEDI-SEAL MEDICARE INDUSTRIES, INC.
K781925 11/22/1978 POUCHES, GAS STERILIZATION MEDICARE INDUSTRIES, INC.
K780996 11/22/1978 RUBELISA TEST KIT MICROBIOLOGICAL ASSOC.
K781222 11/08/1978 ACCUSCREEN T4 NEOMETRICS, INC.
K781539 11/03/1978 ISO-CARE KIT NICE-PAK PRODUCTS, INC.
K781714 11/27/1978 PNEUMOGARD MODEL 1230 NOVAMETRIX MEDICAL SYSTEMS, INC.
K781696 11/03/1978 COPPER-TRAP OLYMPIC MEDICAL CORP.
K781695 11/01/1978 LUBE-LOK OLYMPIC MEDICAL CORP.
K781752 11/03/1978 SCANNER, CT 0450 PFIZER MEDICAL SYSTEMS, INC.
K781797 11/08/1978 PREP TRAY, PREOPERATIVE SKIN PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781852 11/15/1978 GLOVE, SUPERFLEX MOLDED PINNACLE DISTRIBUTORS, INC.
K781808 11/29/1978 SLICK SET, CUFFED POLAMEDCO, INC.
K781545 11/15/1978 AIR POWERED DENTAL HANDPIECE PROMIDENT MFG., LTD.
K781730 11/22/1978 RIA, CORTISOL KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K780775 11/30/1978 MEDICAL PROTEIN HYDROLYSATE "REVITAL" ROBERTSON RESOURCES, INC.
K781737 11/22/1978 EXTRACTOR, SABIAN FOREIGN BODY SABIAN CORP.
K781779 11/08/1978 SANI-DENT DENTURE CLEANER SANDI-DENT
K781798 11/03/1978 TINNITUS MASKER STARKEY LABORATORIES, INC.
K781801 11/03/1978 MAXI-CHAIR SURGICAL MECHANICAL RESEARCH, INC.
K781861 11/15/1978 FILTER, EXTRACORPOREAL BLOOD HOLDER SURGIKOS, INC.
K781753 11/03/1978 TOMOGSCANNER 2 TOMOGSCANNER OK LTD.
K781739 11/27/1978 CAMERA, GCA-10A, LOW ENERGY TOSHIBA MEDICAL SYSTEMS
K781811 11/08/1978 TRANSFER PAK 4R 9006 TRAVENOL LABORATORIES, S.A.
K780479 11/22/1978 DELTA-FLOW TRI-DELTA INTL.
K781872 11/27/1978 CLINAC 2500 VARIAN ASSOC., INC.
K780852 11/03/1978 CLINITEX VIS-X ASPIRATING ACCESSORY VARIAN ASSOC., INC.
K781562 11/15/1978 HEMACHECK VICKERS AMERICA MEDICAL CORP.
K781830 11/15/1978 BIOPSY KIT 781101, ASPIRATION VISTA PRODUCTS, INC.
K780732 11/22/1978 PROCAINAMIDE CALIBRATOR KIT VITEK SYSTEMS, INC.
K781889 11/22/1978 COLLINS PEDALMATE 2 WARREN E. COLLINS, INC.
K781692 11/29/1978 CALIBRATOR, DYNAMIC WATERS ASSOC., INC.
K781561 11/07/1978 ANGIOGRAPHIC GUIDE WIRE WILSON MEDICAL INSTRUMENTS CO.


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