FDA 510(k) Decisions During May, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K780410 05/03/1978 BLOOD PUMP-MODE S10K 3M HEALTH CARE, SARNS
K780637 05/19/1978 HEMATOLOGY SLIDE STAINER A. J. P. SCIENTIFIC, INC.
K780372 05/03/1978 CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. ABBOTT LABORATORIES
K780601 05/19/1978 AIRWAYS ABCO DEALERS, INC.
K780610 05/31/1978 INSTRUMENT LUBRICANT ABCO DEALERS, INC.
K780605 05/09/1978 ISOLATION GOWN ABCO DEALERS, INC.
K780609 05/26/1978 MASK, ISOLATION ABCO DEALERS, INC.
K780723 05/09/1978 OTOSCOPE SPECULA ABCO DEALERS, INC.
K780590 05/09/1978 SHOE COVERS ABCO DEALERS, INC.
K780592 05/03/1978 TRANSFER PIPET ABCO DEALERS, INC.
K780722 05/26/1978 ADVANCED DENTURE SYSTEM ADVANCED MARKETING RESEARCH CO.
K780525 05/19/1978 T-3 UPTAKE (SORBENT) KIT AMERSHAM CORP.
K780771 05/16/1978 MICRO RASPS AMSCO CO.
K780144 05/26/1978 DYNEX BLOOD GAS QUALITY CONTROL SYS. ANALYTICAL PRODUCTS, INC.
K780759 05/19/1978 MODEL 902 STAND APPLIED MEDICAL RESEARCH
K780307 05/19/1978 CARDIAC MINIGRAPH ARCO MEDICAL PRODUCTS CO.
K780297 05/19/1978 CARDIAC MINISCOPE & MINIGRAPH ARCO MEDICAL PRODUCTS CO.
K780673 05/16/1978 CENTRAL CATHETER KIT ARGON MEDICAL CORP.
K780558 05/26/1978 BOTTLE BREATHING DEVICE B & F MEDICAL PRODUCTS, INC.
K780557 05/18/1978 FOLATE REAGENT KIT, ARIA-II SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780552 05/19/1978 COMP. CLIN. CHEM. CONTROL SERUM-DECISION BECKMAN INSTRUMENTS, INC.
K780553 05/19/1978 COMP. CLIN. CHEM. REF. SERUM-BENCHMARK BECKMAN INSTRUMENTS, INC.
K780436 05/12/1978 "RELAX-A-TONE" BIO RESPONSE
K780828 05/31/1978 NURITE II BIO-MEDICAL SYSTEMS CORP.
K780755 05/12/1978 SHORTWAVE DIATHERMY MODEL 802 BIRTCHER CORP.
K780583 05/12/1978 FOME-CUF PVC BIVONA MEDICAL TECHNOLOGIES
K780214 05/03/1978 HEMO FEC BOEHRINGER MANNHEIM CORP.
K780635 05/19/1978 REAGENT SET HDL CHOLESTEROL BOEHRINGER MANNHEIM CORP.
K780634 05/18/1978 SINGLE VIAL 10 SGOT-TRIS BOEHRINGER MANNHEIM CORP.
K780636 05/18/1978 SINGLE VIAL 10 SGPT-TRIS BOEHRINGER MANNHEIM CORP.
K780702 05/19/1978 CSS-60 DIGITAL HEART RATE METER BURDICK CORP.
K780571 05/09/1978 BLOOD PRESSURE MODULE C-V MONITORS CORP.
K780572 05/09/1978 DCG PREAMPLIFIER MODULE C-V MONITORS CORP.
K780630 05/31/1978 CONTROLLER, SERVO, INSPIRON C.R. BARD, INC.
K780694 05/12/1978 HEARING AID BATTERY CHARGER CAHILL ENTERPRISES, INC.
K780345 05/09/1978 PHOTOCOAGULATOR LASER CAVITRON CORP.
K780669 05/03/1978 HEATING AIDS-MODEL C78A & C78B CIRCLE HEARING INSTRUMENTS, INC.
K780709 05/12/1978 IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST CLINICAL ASSAYS, INC.
K780500 05/03/1978 CBR-T3 UPTAKE KIT CLINICAL BIORESEARCH
K780499 05/04/1978 CBR-T3RIA KIT CLINICAL BIORESEARCH
K780649 05/26/1978 FLAME PHOTOMETER, MODEL 435 CORNING MEDICAL & SCIENTIFIC
K780650 05/26/1978 FLAME PHOTOMETER, MODEL 455 CORNING MEDICAL & SCIENTIFIC
K780778 05/31/1978 RTV SILICONE HAND KNEADABLE PUTTY CROWN DELTA CORP.
K780624 05/26/1978 CULDOCENTESIS TRAY CUTTER LABORATORIES, INC.
K780379 05/12/1978 DATA-ZYME TRIGLYCERIDE PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K780412 05/26/1978 TOTAL IRON BINDING CAPACITY DIAGNOSTIC CORP. OF AMERICA
K780663 05/17/1978 CONTACT LENS REMOVER AND INSERTER DMV CONTACT LENS CO.
K780664 05/17/1978 SOFT LENS REMOVER/INSERTER/MANIPULATOR DMV CONTACT LENS CO.
K772393 05/09/1978 CARROLL TENDON RETRIEVER EDWARD WECK, INC.
K780520 05/16/1978 VAS APPROXIMATOR EDWARD WECK, INC.
K780173 05/03/1978 LYPOPROTEIN CHOLESTEROL TEST KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K772424 05/09/1978 RYUSEI ERCONA CORP.
K780578 05/25/1978 SONOGRAF EDP REAL-TIME ADAPTER FOLEY, LARDNER, HOLLABAUGH & JACOBS
K780677 05/17/1978 4600 RECORDER G & W APPLIED SCIENCE LABORATORIES
K780506 05/03/1978 CARBON DIOXIDE REAGENTS GAMMA ENTERPRISES, INC.
K780504 05/03/1978 CREATINE PHOSPHOKINASE (CPK) GAMMA ENTERPRISES, INC.
K780505 05/03/1978 SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE GAMMA ENTERPRISES, INC.
K780507 05/03/1978 SERUM GLUTAMIC-PYRUVIC TRANSAMINASE GAMMA ENTERPRISES, INC.
K780577 05/19/1978 PLATELETS/CU MM GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K780704 05/12/1978 COLUMBIA AGAR WITH 5% RABBIT BLOOD GRANITE DIAGNOSTICS, INC.
K780568 05/26/1978 DURAN FLEXIBLE RING HANCOCK LABORATORIES, INC.
K780513 05/19/1978 ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 HARLECO
K780514 05/19/1978 ULTRACHEM CREATININE 64972, CENTRIFUCHEM HARLECO
K780515 05/19/1978 ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM HARLECO
K780523 05/19/1978 ULTRACHEM ENZYMATIC CHOLESTEROL 65025 HARLECO
K780524 05/19/1978 ULTRACHEM T-BILI 64971 GILFORD 3500 HARLECO
K780705 05/19/1978 INFUSION PUMP-MODEL 2616 HARVARD APPARATUS, INC.
K780768 05/26/1978 MODEL 5621A INTERFACE HEWLETT-PACKARD CO.
K780651 05/09/1978 ULTRASONIC DIAGNOSTIC TRANSDUCER HOFFREL INSTRUMENTS, INC.
K780427 05/19/1978 RP-510/RP-514 PARALLEL PLATE DIALYZERS HOSPAL MEDICAL CORP.
K780626 05/26/1978 VENTURI OXYGEN MASK HOSPITAK, INC.
K780711 05/26/1978 MICRO-RING HOWMEDICA CORP.
K780330 05/12/1978 TOTAL HIP, LORD MADREPORIC HOWMEDICA CORP.
K780464 05/03/1978 LELECTIVE KINETIC SYSTEM-60 HYCEL, INC.
K780744 05/12/1978 BRINKER TISSUE RETRACTORS HYGIENIC DENTAL MFG., CO., THE
K780743 05/12/1978 CLAMP FORCEPS HYGIENIC DENTAL MFG., CO., THE
K780746 05/12/1978 HYGIENIC RUBBER DAM FRAME HYGIENIC DENTAL MFG., CO., THE
K780745 05/12/1978 RUBBER DAM HYGIENIC DENTAL MFG., CO., THE
K780729 05/18/1978 LAS-R HUMAN COMPLEMENT CLQ TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780482 05/03/1978 KOVA TROL III ICL SCIENTIFIC
K780521 05/12/1978 SPECTROPHOTOMETER, ATOMIC ABSORPTION INSTRUMENTATION LABORATORY CO.
K780522 05/12/1978 SPECTROPHOTOMETERS, ATOMIC ABSORPTION INSTRUMENTATION LABORATORY CO.
K780820 05/31/1978 HEARING AID MODEL 8148 INT'L HEARING AIDS, INC.
K780821 05/31/1978 HEARING AID MODEL 8160H INT'L HEARING AIDS, INC.
K780822 05/31/1978 HEARING AID MODEL 8160U INT'L HEARING AIDS, INC.
K780730 05/09/1978 FIGURETRIM JAY-MAR INTERNATIONAL ENTERPRISES, IN
K780779 05/19/1978 ECONO-FLOAT WATER FLOTATION MATTRESS JEFFERSON INDUSTRIES, INC.
K780519 05/09/1978 FILTER TUBE JELCO LABORATORIES
K780508 05/03/1978 QUANTITOPE 125I-FOLATE RADIOASSAY KIT KALLESTAD LABORATORIES, INC.
K780712 05/17/1978 KERR DISCOVERY DISPOSABLE FLUORIDE TRAY KERR CORPORATION (DANBURY)
K780701 05/16/1978 DENTAL OFFICE ENVIRONMENT CONTROL UNIT LAMINAIRE CORP.
K780541 05/19/1978 PRESSURE MODULES MODELS 1855 & 1856 LIFE-TECH INSTRUMENTS, INC.
K780341 05/26/1978 SCINTILLATION, LIQUID, RACKBETA LKB INSTRUMENTS, INC.
K780263 05/03/1978 SHIELD LORVIC CORP.
K780534 05/19/1978 UREA NITROGEN (ENZYMATIC) MACOMB CHEMICAL CO.
K780698 05/12/1978 STIMULATORS, NERVE, ELECTRICAL MED GENERAL
K780615 05/04/1978 BLOOD CULTURE MEDIA MEDA STAT DIAGNOSTICS, INC.
K780645 05/03/1978 HMD-2000 BATTERY-POWERED MINI-DRILL, THE MEDISHIELD, INC.
K780675 05/09/1978 STERILE 100% SILICONE FOLEY CATHETER MEDLINE INDUSTRIES, INC.
K780676 05/09/1978 STERILE CLOSED SYSTEM MEDLINE INDUSTRIES, INC.
K780327 05/18/1978 GENERATORS, ATRIAL INHIBITED PULSE MEDTRONIC VASCULAR
K780758 05/19/1978 NEUROLOGICAL SCREENING STIMULATOR M 3623 MEDTRONIC VASCULAR
K780579 05/19/1978 SUBCUPASS TUNNELING TOOL MEDTRONIC VASCULAR
K780446 05/19/1978 SUTURELESS MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR
K780348 05/18/1978 EPILATION TYPE DEVICE MEHL, THOMAS L.
K780501 05/19/1978 ELECTRODE TESTER MG MEDICAL ELECTRONICS
K780432 05/26/1978 ARRHYTHMIA PROGRAM MODULE MIDWEST ANALOG & DIGITAL, INC.
K780631 05/03/1978 NDM INFANT ECG PACKPAD NEW DIMENSIONS IN MEDICINE, INC.
K780697 05/03/1978 GOAT ANTI-INFLUENZA ANTISERA ATEXAS NORTHEAST BIOMEDICAL LABS., INC.
K780696 05/03/1978 GOAT ANTIINFLUENZA ANTISERA AUSSR NORTHEAST BIOMEDICAL LABS., INC.
K780747 05/26/1978 SNAP-WAY NORTHWEST ORTHODONTICS, INC.
K780699 05/03/1978 EARETTE HEARING AID OPTICON CORP.
K780763 05/16/1978 ENTRAX TRACTION UNIT ORTHOPEDIC EQUIPMENT CO., INC.
K780356 05/31/1978 OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 OUTPUT, INC.
K780542 05/19/1978 ALFATEST PANMED, INC.
K780576 05/19/1978 125-I LABELED HUMAN LUTEINIZING HORMONE PCL-RIA, INC.
K780512 05/03/1978 AUTO/STAT KIT PIERCE CHEMICAL CO.
K780826 05/26/1978 BILIRUBIN RAPID STAT KIT PIERCE CHEMICAL CO.
K780825 05/26/1978 TRIGLYCERIDE C-37 RAPID STAT KIT PIERCE CHEMICAL CO.
K780587 05/25/1978 GYNESURG POLAMEDCO, INC.
K780683 05/03/1978 TISSUE PULSATOR PULSATOR CORP.
K780449 05/16/1978 BETA CAP SYSTEM QUINTON, INC.
K780667 05/03/1978 HEARING AID-MODEL 2010 RADIOEAR CORP.
K780586 05/16/1978 MICROCLIP, WILLIAMS RICHARD'S MEDICAL EQUIP., INC.
K780713 05/12/1978 CULTURE SWAB ROYAL SCIENTIFIC, INC.
K780462 05/12/1978 ALT(GPT) UNI-UV, SGPT SCLAVO, INC.
K780463 05/12/1978 AST(GOT) UNI-UV, SGOT SCLAVO, INC.
K780402 05/12/1978 POWER STRIDER SEIDEL MANUFACTURING, INC.
K780762 05/26/1978 EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE SHILEY, INC.
K780487 05/09/1978 FETAL MONITORING SYSTEM SONICAID, INC.
K780529 05/09/1978 MYOCATH KIT SORENSEN RESEARCH
K780545 05/26/1978 SR-PLUS DIRECT CHOLESTEROL TEST STANBIO LABORATORY
K780360 05/26/1978 MASSAGER, GUM/SSAGE POWERED GUM SUNBEAM CORP.
K780639 05/03/1978 EMIT CENTRIFICHEM THYROXINE ASSAY SYVA CO.
K780648 05/31/1978 MODIFIED UNTREATED TAMPAX TAMPONS TAMPAX, INC.
K780543 05/26/1978 THERMAJUST CIRCU-TEMP TECHHNILAB INSTRUMENTS, INC.
K780777 05/16/1978 BAGS, PLASTIC, STERILE FOR GENERATORS TELECTRONICS, INC.
K780638 05/26/1978 ACCESSORY HDL CHOLESTEROL REAGENT SET THE DOW CHEMICAL CO.
K780710 05/09/1978 AIR MASSAGE SYSTEM THERACOM C/O ARENT, FOX, KINTNER, PLOTKI
K780224 05/19/1978 MICROCELL COUNTER MODEL CC-108 TOA MEDICAL ELECTRONICS USA, INC.
K780749 05/16/1978 SPEECH AUDIOMETER RA 226 TRACOR INSTRUMENTS, INC.
K780381 05/16/1978 RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE TRAVENOL LABORATORIES, S.A.
K780385 05/16/1978 RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE TRAVENOL LABORATORIES, S.A.
K780473 05/16/1978 ILEX STOMA SEAL AND PROTECTIVE CREAM VIRGIL PICHIERRI
K780584 05/16/1978 PULMONARY FUNCTION TESTER WARREN E. COLLINS, INC.
K780642 05/03/1978 LITECAST SOLDER WILLIAMS GOLD REFINING CO., INC.
K780752 05/26/1978 PROPHYLAXIS ANGLE YOUNG DENTAL MANUFACTURING CO 1, LLC.


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