FDA 510(k) Applications Received During March, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K780410 03/13/1978 BLOOD PUMP-MODE S10K 3M HEALTH CARE, SARNS
K780372 03/08/1978 CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. ABBOTT LABORATORIES
K780472 03/24/1978 INFANT INCUBATOR AIR-SHIELDS, INC.
K780503 03/29/1978 INFUSION PUMP AIR-SHIELDS, INC.
K780492 03/27/1978 GAMMA STIK 125I T3 UPTAKE KIT ALPHA GAMMA LABORATORY
K780488 03/27/1978 INSTRUMENT AND ACCESSORY KIT AMERICAN HOSPITAL SUPPLY CORP.
K780443 03/20/1978 SGOT/AST REAGENT SYSTEM AMERICAN MONITOR CORP.
K780343 03/02/1978 ARRHYTHMIA TREND ENHANCEMENT AMERICAN OPTICAL CORP.
K780497 03/28/1978 SPHERISTEM TOTAL HIP PROSTHESIS AMERICAN ORTOMED CORP.
K780525 03/31/1978 T-3 UPTAKE (SORBENT) KIT AMERSHAM CORP.
K780516 03/30/1978 GENTAMICIN RIA KIT ANTIBODIES INC.
K780358 03/06/1978 ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 APPLIED MEDICAL RESEARCH
K780350 03/03/1978 I.V. START KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780477 03/24/1978 PHYSIOLOGICAL PRESSURE TRANSDUCER BELL & HOWELL INSTRUMENTS
K780436 03/17/1978 "RELAX-A-TONE" BIO RESPONSE
K780375 03/08/1978 PAVLIK HARNESS BIOMET, INC.
K780357 03/06/1978 TITANIUM MULLER TOTAL HIP BIOMET, INC.
K780510 03/30/1978 NUCLEAR STETHOSCOPE BIOS, INC.
K780439 03/20/1978 PRECIMAT GLYCEROL BOEHRINGER MANNHEIM CORP.
K780475 03/24/1978 DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT BURROUGHS WELLCOME CO.
K780409 03/13/1978 COLOPLAST-DURASEAL OSTOMY APPLIANCE C.R. BARD, INC.
K780438 03/20/1978 SAFETY SPRING GUIDES, TEFLON COATED C.R. BARD, INC.
K780347 03/02/1978 RIA SYS. FOR HUMAN GROWTH HORMONE CALBIOCHEM-BEHRING CORP.
K780367 03/07/1978 RIA SYS. FOR HUMAN LUTEINIZING HORMONE CALBIOCHEM-BEHRING CORP.
K780433 03/17/1978 FIBER OPTIC ADJUSTABLE HEADLIGHT CAMERON-MILLER, INC.
K780666 03/10/1978 DAYSTAR SELECTRA & SELECTRA/ORBITER CASTLE CO.
K780376 03/08/1978 MINIDENTOFLEX NEW POLISHING SYSTEM CAVITRON CORP.
K780345 03/01/1978 PHOTOCOAGULATOR LASER CAVITRON CORP.
K780377 03/08/1978 PINIDENTOFLEX DENTAL POLISHER CAVITRON CORP.
K780337 03/02/1978 THERMOLYSIS GENERATOR CLARE, INC.
K780366 03/06/1978 SOLID-OX EMERGENCY OXYGEN CLEANWELD PRODUCTS, INC.
K780459 03/23/1978 CLEARTONE MODEL-1 & 2 HEARING AIDS CLEARTONE CUSTOM HEARING INSTRUMENTS
K780498 03/28/1978 CBR-DIGOXIN ANTISERUM CLINICAL BIORESEARCH
K780500 03/28/1978 CBR-T3 UPTAKE KIT CLINICAL BIORESEARCH
K780499 03/28/1978 CBR-T3RIA KIT CLINICAL BIORESEARCH
K780419 03/14/1978 SUBCLAVIAN TRAY CONCORD LABORATORIES, INC.
K780387 03/10/1978 VABRA ABORTION UNIT COOPER LABORATORIES
K780453 03/20/1978 STANICOR THETA MODEL 221 CARDIAC PACER CORDIS CORP.
K780401 03/13/1978 THYRO-ZYME-T4 ASSAY KIT COULTER ELECTRONICS, INC.
K780391 03/10/1978 PODIATRIC MATERIAL CROWN DELTA CORP.
K780496 03/28/1978 TRAVELAIR AND STATIONAIR CRYOMED CORP.
K780379 03/08/1978 DATA-ZYME TRIGLYCERIDE PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K780485 03/27/1978 PREBYPASS FILTER DELTA MEDICAL INDUSTRIES
K780518 03/31/1978 ULTRANOVAR, DENTAL U.V. CURING LAMP DEMETRON RESEARCH CORP.
K780469 03/22/1978 PANORAMIC X-RAY, DENTAL DEN-TAL-EZ MFG CO., INC.
K780412 03/15/1978 TOTAL IRON BINDING CAPACITY DIAGNOSTIC CORP. OF AMERICA
K780494 03/27/1978 AMIKACIN DIAGNOSTIC PRODUCTS CORP.
K780495 03/27/1978 DIGITOXIN DIAGNOSTIC PRODUCTS CORP.
K780470 03/22/1978 H.P. MEDICAL GRADE SILICONE TUBING DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K780484 03/27/1978 SILASTIC BRAND PENILE IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K780454 03/20/1978 ACTIVE-LIFE E. R. SQUIBB & SONS, INC.
K780511 03/30/1978 SNAP-FIT E. R. SQUIBB & SONS, INC.
K780349 03/03/1978 VAGINAL RETRACTOR EDWARD WECK, INC.
K780520 03/31/1978 VAS APPROXIMATOR EDWARD WECK, INC.
K780493 03/27/1978 ELECATH PLASTIC JACKETED GUIDEWIRE ELECTRO-CATHETER CORP.
K780359 03/06/1978 OXYGEN REGULATOR/FLOWMETER ERIE MFG., CO.
K780506 03/30/1978 CARBON DIOXIDE REAGENTS GAMMA ENTERPRISES, INC.
K780504 03/30/1978 CREATINE PHOSPHOKINASE (CPK) GAMMA ENTERPRISES, INC.
K780505 03/30/1978 SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE GAMMA ENTERPRISES, INC.
K780507 03/30/1978 SERUM GLUTAMIC-PYRUVIC TRANSAMINASE GAMMA ENTERPRISES, INC.
K780471 03/24/1978 GASTRIC LAVAGE KIT GAYMAR INDUSTRIES, INC.
K780480 03/27/1978 CT/T INDEPENDENT DIAGNOSTIC CENTER GENERAL ELECTRIC CO.
K780491 03/27/1978 DATA CAMERA GENERAL ELECTRIC CO.
K780425 03/17/1978 BIOPHYSICAL MONITORING SYSTEM GOULD, INC.
K780513 03/30/1978 ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 HARLECO
K780514 03/30/1978 ULTRACHEM CREATININE 64972, CENTRIFUCHEM HARLECO
K780515 03/30/1978 ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM HARLECO
K780523 03/31/1978 ULTRACHEM ENZYMATIC CHOLESTEROL 65025 HARLECO
K780524 03/31/1978 ULTRACHEM T-BILI 64971 GILFORD 3500 HARLECO
K780363 03/06/1978 PHONIC EAR HC ELECTRONICS
K780429 03/17/1978 TOURNEQUET, NON-PNEUMATIC HEMOX, INC.
K780417 03/14/1978 ASEPTIC TRANSFER SET HEYER SCHULTE CORP.
K780414 03/15/1978 OCTOPUS HITRON CORP.
K780428 03/17/1978 ROCHE TSH RIA HOFFMANN-LA ROCHE, INC.
K780427 03/17/1978 RP-510/RP-514 PARALLEL PLATE DIALYZERS HOSPAL MEDICAL CORP.
K780445 03/20/1978 LIQUID CRYSTAL DISPLAY DIGITAL WATCH HUGHES AIRCRAFT CO.
K780464 03/22/1978 LELECTIVE KINETIC SYSTEM-60 HYCEL, INC.
K780452 03/21/1978 THERA-PAK HYDRO-MED PRODUCTS, INC.
K780526 03/31/1978 CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM I M, INC.
K780482 03/27/1978 KOVA TROL III ICL SCIENTIFIC
K780521 03/31/1978 SPECTROPHOTOMETER, ATOMIC ABSORPTION INSTRUMENTATION LABORATORY CO.
K780522 03/31/1978 SPECTROPHOTOMETERS, ATOMIC ABSORPTION INSTRUMENTATION LABORATORY CO.
K780437 03/20/1978 PACEMAKER, MODEL 252, C-MOS INTERMEDICS, INC.
K780416 03/14/1978 PANTRIDGE MK III DEFIBRILLATOR/MONITOR IPCO CORP.
K780519 03/31/1978 FILTER TUBE JELCO LABORATORIES
K780386 03/10/1978 K-Y LUBRICATING JELLY JOHNSON & JOHNSON PROFESSIONALS, INC.
K780508 03/30/1978 QUANTITOPE 125I-FOLATE RADIOASSAY KIT KALLESTAD LABORATORIES, INC.
K780408 03/13/1978 MICRONET LIGHT DRESSING SPONGE KENDALL RESEARCH CENTER
K780384 03/09/1978 IMPROVED DYCAL L.D. CAULK CO.
K780344 03/01/1978 GAMMA COUNTER LKB INSTRUMENTS, INC.
K780340 03/01/1978 IMV SYSTEM LKB INSTRUMENTS, INC.
K780338 03/01/1978 MINYSTAG MN-1 LKB INSTRUMENTS, INC.
K780341 03/01/1978 SCINTILLATION, LIQUID, RACKBETA LKB INSTRUMENTS, INC.
K780460 03/22/1978 DENTAL AIR BRUSH M. JOEL GEBHART, D.D.S.
K780351 03/03/1978 NORMAL UNASSAYED CONTROL SERA MACOMB CHEMICAL CO.
K780447 03/20/1978 URIC ACID REFERENCE SERA MACOMB CHEMICAL CO.
K780382 03/10/1978 AUDIOMETER, PORTABLE, AIR CONDUCTION MAICO HEARING INSTRUMENTS, INC.
K780353 03/03/1978 DRI-LYTE MALLINCKRODT CRITICAL CARE
K780440 03/20/1978 CHAMBER, AEROBIC MARION LABORATORIES, INC.
K780346 03/01/1978 MIF PROCEDURE KIT MARION LABORATORIES, INC.
K780489 03/27/1978 SPINE BOARD MARULLO, BALDWIN, FRIEDEN, GATEWOOD,
K780430 03/17/1978 LITHICRON F PROGRAMMABLE PULSE GEN MEDCOR, INC.
K780370 03/07/1978 STAND UP TOILET MEDICAL SPECIALTY PRODUCTS, INC.
K780371 03/07/1978 TILT TYPE AC POWERED HOSPITAL BED MEDICAL SPECIALTY PRODUCTS, INC.
K780444 03/20/1978 NERVTRON-RX MEDIX CORP.
K780369 03/07/1978 MODUMED MUGE MEDTRONIC VASCULAR
K780368 03/07/1978 MODUMED MUGX MEDTRONIC VASCULAR
K780446 03/20/1978 SUTURELESS MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR
K780348 03/02/1978 EPILATION TYPE DEVICE MEHL, THOMAS L.
K780501 03/28/1978 ELECTRODE TESTER MG MEDICAL ELECTRONICS
K780383 03/09/1978 COUNTER, RADIOASSAY, AUTO., MICROMEDIC MICROMEDIC SYSTEMS
K780432 03/17/1978 ARRHYTHMIA PROGRAM MODULE MIDWEST ANALOG & DIGITAL, INC.
K780393 03/10/1978 BIOSTATOR GLUCOSE ANALYZER MILES LABORATORIES, INC.
K780352 03/03/1978 IMMUNOZYME TOXOPLASMA ANTIBODY MILLIPORE CORP.
K780361 03/06/1978 T3 UPTAKE TEST MONOBIND
K780396 03/13/1978 NASAL GASTRIC TUBE RETAINER MOR-MAC, INC.
K780458 03/23/1978 TRANSCUTANEOUS OXYGEN PERFUSION MONITOR NARCO AIR-SHIELDS
K780405 03/13/1978 INFANT ELECTROSURGICAL GROUNDING PAD NEW DIMENSIONS IN MEDICINE, INC.
K780490 03/27/1978 NEIA-FERRITIN ENZYMEIMMUNOASSAY NEW ENGLAND IMMUNOLOGY ASSOC.
K780400 03/13/1978 DEN-Z-ORB NICE-PAK PRODUCTS, INC.
K780415 03/14/1978 VIVONEX DELIVERY SYSTEM NORWICH PHARMACAL CO.
K780502 03/29/1978 NOVA AIR FLOATATION SYSTEM NOVA HEALTH SYSTEMS, INC.
K780486 03/27/1978 STIKSEP-T3 KIT NUCLEAR DIAGNOSTICS, INC.
K780423 03/16/1978 STIKSEP-T4 RIA KIT NUCLEAR DIAGNOSTICS, INC.
K780468 03/22/1978 CLINICAL GRAPHICS ANALYZER NUMONICS CORP.
K780398 03/13/1978 CUP, ACETABULAR, LONG POSTERIOR WALL ORTHOPEDIC EQUIPMENT CO., INC.
K780397 03/13/1978 ORTHOPEDIC FORCEPS ORTHOPEDIC EQUIPMENT CO., INC.
K780356 03/06/1978 OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 OUTPUT, INC.
K780413 03/15/1978 LOW IIONIC STRENGTH SOLUTION PFIZER, INC.
K780512 03/30/1978 AUTO/STAT KIT PIERCE CHEMICAL CO.
K780422 03/17/1978 PINWHEEL PROJECTS IN HEALTH
K780426 03/17/1978 BODY WARMER Q-MATIC CORP.
K780449 03/20/1978 BETA CAP SYSTEM QUINTON, INC.
K780404 03/13/1978 ECG MONITORING SYSTEM, QUINTON, INC.
K780399 03/13/1978 INSTRUMENT CLEANING BRUSH RANSOM AND RANDOLPH
K780462 03/23/1978 ALT(GPT) UNI-UV, SGPT SCLAVO, INC.
K780463 03/23/1978 AST(GOT) UNI-UV, SGOT SCLAVO, INC.
K780402 03/13/1978 POWER STRIDER SEIDEL MANUFACTURING, INC.
K780355 03/03/1978 ATROXIN SIGMA CHEMICAL CO.
K780487 03/27/1978 FETAL MONITORING SYSTEM SONICAID, INC.
K780465 03/22/1978 VOLUME CONTROL DEVICE VCD-150 SORENSEN RESEARCH
K780364 03/06/1978 MANIFOLD KIT SPICA, INC.
K780365 03/06/1978 OXYGEN/NITROUS OXIDE OUTLET SPICA, INC.
K780360 03/06/1978 MASSAGER, GUM/SSAGE POWERED GUM SUNBEAM CORP.
K780483 03/27/1978 FIBER OPTIC HANDPIECE SYNTEX CORP.
K780388 03/10/1978 ANALYZER, 100, BICHROMATIC, ABBOTT SYVA CO.
K780380 03/10/1978 ANALYZER, FAST, CENTRIFUGAL, GEMSAEC SYVA CO.
K780461 03/23/1978 ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 SYVA CO.
K780467 03/22/1978 EMIT ANTIEPILEPTIC DRUG CALIBRATORS SYVA CO.
K780466 03/22/1978 EMIT CARBAMAZEPINE ASSAY SYVA CO.
K780441 03/20/1978 THEOPHYLLINE ASSAY TO THE CENTRIFICHEM SYVA CO.
K780442 03/20/1978 THEOPHYLLINE ASSAY TO THE GEMSAEC SYVA CO.
K780411 03/13/1978 TAYLOR CATHETER HOLDER TAYLOR CATHETER HOLDER MFG.
K780448 03/20/1978 TRANSPORTABLE OXYGEN PURITY ANALYZER TAYLOR INSTRUMENT ANALYTICS CO.
K780373 03/08/1978 STAC SYSTEM TECHNICON INSTRUMENTS CORP.
K780420 03/15/1978 GENERATOR, PULSE, CARDIAC, IMPLANTABLE TELECTRONICS, INC.
K780421 03/15/1978 GENERATOR, PULSE, CARDIAC, IMPLANTABLE TELECTRONICS, INC.
K780418 03/14/1978 BURN DRESSING PAD THE OWENBY CO.
K780342 03/02/1978 SPECTROPHOTOMETERS THE PERKIN-ELMER CORP.
K780394 03/13/1978 GAUZE FLUFF THE TORRENT CORP.
K780478 03/24/1978 LIQUID CRYSTAL THERMOGRAPHIC SYSTEM THERMAL IMAGERY, INC.
K780474 03/24/1978 AUDIOMETER CALIBRATOR MODEL RA 310 TRACOR INSTRUMENTS, INC.
K780450 03/20/1978 TRACOR RA 410 AUDIOMETER TRACOR INSTRUMENTS, INC.
K780407 03/13/1978 2C7125 BLOW BOTTLE TRAVENOL LABORATORIES, S.A.
K780406 03/13/1978 2C7153 NEBULIZER CAP TRAVENOL LABORATORIES, S.A.
K780517 03/31/1978 CARDIOTOMY RESERVOIR TRAVENOL LABORATORIES, S.A.
K780354 03/03/1978 CRYOCYTE PACK TRAVENOL LABORATORIES, S.A.
K780481 03/27/1978 I.V. LEVER CLAMP TRAVENOL LABORATORIES, S.A.
K780456 03/21/1978 NEBULIZER HEATER TRAVENOL LABORATORIES, S.A.
K780381 03/10/1978 RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE TRAVENOL LABORATORIES, S.A.
K780385 03/10/1978 RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE TRAVENOL LABORATORIES, S.A.
K780479 03/27/1978 DELTA-FLOW TRI-DELTA INTL.
K780395 03/13/1978 IMAGER, BODY SECTION, RADIONUCLIDE UNION CARBIDE CORP.
K780362 03/06/1978 SPECTROFLUOROMETER SF-330 VARIAN ASSOC., INC.
K780390 03/10/1978 SPECTROPHOTOMETER, ABSORPTION, ATOMIC VARIAN ASSOC., INC.
K780531 03/30/1978 MILLER TABLE VICTOR JOHN MANLEY
K780473 03/24/1978 ILEX STOMA SEAL AND PROTECTIVE CREAM VIRGIL PICHIERRI
K780455 03/20/1978 QUANTITATIVE DETERMINATION OF PORPHYRINS WHALE SCIENTIFIC, INC.
K780389 03/10/1978 HDL REAGENT SET FOR LIPOPROTEINS WORTHINGTON BIOCHEMICAL CORP.


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