FDA 510(k) Decisions During August, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781097 08/14/1978 INOCULUM STDIZING SYS., INOCUPAC 3M COMPANY
K781423 08/31/1978 DUAL COMPONENT STANDARDS ABBOTT LABORATORIES
K780877 08/14/1978 ENEMA BAG ABCO DEALERS, INC.
K781279 08/10/1978 SUCTION CANISTER ABCO DEALERS, INC.
K781251 08/31/1978 THREADED PIN, SELF DRILLING ACE ORTHOPEDIC MANUFACTURING CO.
K780853 08/14/1978 OP-SITE ADHESIVE DRAPES ACME UNITED CORP.
K781276 08/10/1978 X-RAY, PORTABLE AIR-SHIELDS, INC.
K780927 08/09/1978 TI-COMFORTER ALDEN PRODUCTS CO.
K781241 08/14/1978 UNISTAT BILIRUBINOMETER AMERICAN OPTICAL CORP.
K781324 08/31/1978 ALP TEST ANALYTICAL & RESEARCH CHEMICALS, INC.
K781308 08/31/1978 GLUCOLOUR ANALYTICAL & RESEARCH CHEMICALS, INC.
K781307 08/31/1978 GLUCOSE DETERM. KIT ANALYTICAL & RESEARCH CHEMICALS, INC.
K781309 08/31/1978 GOT PROCEDURE ANALYTICAL & RESEARCH CHEMICALS, INC.
K781323 08/31/1978 LDH PROCEDURE ANALYTICAL & RESEARCH CHEMICALS, INC.
K781305 08/31/1978 UREA NITROGEN ANALYTICAL & RESEARCH CHEMICALS, INC.
K781306 08/31/1978 UREA NITROGEN TEST KIT ANALYTICAL & RESEARCH CHEMICALS, INC.
K781283 08/14/1978 READER, INOCULUM, STDIZED. ANALYTICAL PRODUCTS, INC.
K781311 08/21/1978 ELECTRODE, NEEDLE, CFM APPLIED MEDICAL RESEARCH
K781278 08/31/1978 GLOVES, PROCEDURE ARBROOK MFG. CORP.
K781429 08/31/1978 HAND-TROL CONNECTOR EXTENDER ASPEN LABORATORIES, INC.
K781072 08/10/1978 TRAP-BLOOD VESSEL STABILIZATION DEVICE AYER, PATRICK, M.D.
K781135 08/14/1978 INGROWN TOENAIL APPLIANCE, OR BARMORE, BARBARA
K781138 08/14/1978 SPECTROPHOTOMETER BAUSCH & LOMB, INC.
K781036 08/10/1978 AUTO-SYRINGE INFUSION SET BAXTER HEALTHCARE CORP.
K781331 08/17/1978 A-V FISTULA NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781330 08/31/1978 BLOOD LEVEL DETECTOR-MODEL 7601 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781337 08/11/1978 CONJUGATED BILE ACIDS RIA KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781149 08/14/1978 CPK-L TUBE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781100 08/14/1978 DELTA TEST AMYLASE/LIPASE CONTS. I,II BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781182 08/14/1978 MICRO THYROXINE REAGENT SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781304 08/14/1978 TRANSPORT MEDIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781093 08/14/1978 HDL CENTRIFIKIT BECKMAN INSTRUMENTS, INC.
K781355 08/31/1978 ICS NORMAL CONTROL SERUM BECKMAN INSTRUMENTS, INC.
K781006 08/31/1978 IMMUNOCHEMISTRY SYS. MANUAL MODE BECKMAN INSTRUMENTS, INC.
K781170 08/14/1978 QUANTIMUNE HTSH IRMA HUMAN THYROID BIO-RAD
K780869 08/14/1978 CELL CULTURE LINES BIOASSAY SYSTEMS RESEARCH CORP.
K781389 08/21/1978 BIOMET CONCENTRIC HEX SCREW BIOMET, INC.
K780848 08/23/1978 PORTABLE CLOSED WOUND SUCTION EVACUATOR BIOMET, INC.
K781294 08/14/1978 PROSTHESIS, KNEE, TOTAL BIOMET, INC.
K781075 08/14/1978 STATTEK-GLUCOSE LOW LEVEL BOEHRINGER MANNHEIM CORP.
K780993 08/10/1978 ULTRASOUND IMAGING SYSTEM BOEHRINGER MANNHEIM CORP.
K781347 08/21/1978 CAMCO QUIK STAIN II CAMBRIDGE CHEMICAL PRODUCTS, INC.
K781152 08/31/1978 ELECTROCARDIOGRAPHIC ECG RECORDER CARDIO-DYNAMICS LABORATORIES, INC.
K781136 08/10/1978 TEMPERATURE MODULE, DUAL CAVITRON CORP.
K781039 08/31/1978 OXY-ON DIGITAL OXYGEN TIMER CHAMBERS & SADLER MFG.
K781207 08/10/1978 DOUCHE KIT, SOMETHING PERSONAL CHATTEN DRUG & CHEMICAL CO.
K780934 08/14/1978 IN VITRO TOBRAMYCIN RIA KIT CLINICAL ASSAYS, INC.
K781235 08/14/1978 IV VITRO GAMMADAB T4 RIA KIT CLINICAL ASSAYS, INC.
K781268 08/14/1978 CHAIR, VESTIBULAR, ROTARY, COMPUT. CONTRAVES
K781099 08/14/1978 SURGICAL GOWNS AND DRAPES CONVERTORS
K781058 08/23/1978 C-DAK 4000 ARTIFICIAL KIDNEY CORDIS CORP.
K781238 08/31/1978 KIDNEY, ARTIFICIAL, C-DAK 1.5 CORDIS CORP.
K781237 08/31/1978 KIDNEY, ARTIFICIAL, C-DAK 2.0 CORDIS CORP.
K781217 08/21/1978 DATA TERMINAL MODEL 722 CORNING MEDICAL & SCIENTIFIC
K781253 08/21/1978 BUN (UREASE) REAGENT COULTER ELECTRONICS, INC.
K781083 08/31/1978 DENTAL SILICONE IMPRESSION MATERIAL CROWN DELTA CORP.
K781363 08/14/1978 CAST SHOE CUTLER BIOMEDICAL
K781059 08/14/1978 CUTTER/COMPUR MINI CENTRIFUGE CUTTER LABORATORIES, INC.
K780246 08/31/1978 PACEMAKER, ELECTRODE, PERMANENT & TEMP. DAIG CORP.
K781212 08/14/1978 HEARING AID, MODEL 783DU DANAVOX, INC.
K781345 08/31/1978 ULTRAFILL- ULTRABOUND DEMETRON RESEARCH CORP.
K781244 08/31/1978 TEMP. CROWN MSTERIAL FOR TEETH DEN-MAT CORP.
K781151 08/31/1978 REPROSIL DENTSPLY INTL.
K781169 08/31/1978 IMAGE DERINGER-NEY INC.
K780868 08/14/1978 CHEST ROLLS DEVON INDUSTRIES, INC.
K780866 08/14/1978 CHEST ROLLS HOLDER DEVON INDUSTRIES, INC.
K780865 08/21/1978 MAGNETIC DRAPE - INSTRUMENT HOLDER DEVON INDUSTRIES, INC.
K780867 08/14/1978 PAD HOLDER KIT DEVON INDUSTRIES, INC.
K781310 08/31/1978 HUMAN CHORIONIC GONADO.-BETA RIA KIT DIAGNOSTICS BIOCHEM CANADA, INC.
K760897 08/31/1978 STERILE URETHRAL CATHETER KIT DIAMED DIVISION ILL. TOOL WORKS, INC.
K781088 08/18/1978 OSTOMY APPLIANCE BELT E. R. SQUIBB & SONS, INC.
K781144 08/23/1978 ANALYZER, PACER SYSTEM, PSA-5 EDWARDS PACEMAKER SYSTEMS
K781111 08/31/1978 LEAD CONVERSION KIT, MODEL 341 EDWARDS PACEMAKER SYSTEMS
K781124 08/10/1978 CPK ISOENZYME REAGENT ELECTROPHORESIS CORP. OF AMERICA
K781118 08/10/1978 ECA BUFFER PH 8.8 ELECTROPHORESIS CORP. OF AMERICA
K781116 08/10/1978 ECA BUFFER, PH 816 ELECTROPHORESIS CORP. OF AMERICA
K781119 08/14/1978 ECA HEME BUFFER ELECTROPHORESIS CORP. OF AMERICA
K781117 08/10/1978 ECA PREP ELECTROPHORESIS CORP. OF AMERICA
K781121 08/14/1978 HEMOLYSE ELECTROPHORESIS CORP. OF AMERICA
K781125 08/10/1978 LDH ISOENZYME REAGENT ELECTROPHORESIS CORP. OF AMERICA
K781122 08/31/1978 LIPOPROTEIN STAIN ELECTROPHORESIS CORP. OF AMERICA
K781123 08/10/1978 PONCEAU S ELECTROPHORESIS CORP. OF AMERICA
K781120 08/10/1978 TRICHLORACETIC ACID 7.5% ELECTROPHORESIS CORP. OF AMERICA
K781215 08/31/1978 TEST MODULE MODEL DM-352 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780784 08/14/1978 ASPIRATION NEEDLE FERRIS MFG. CORP.
K781246 08/10/1978 FOAM COMFORT RINGS FIBRE FORMATIONS, INC.
K781233 08/14/1978 IV ARMBOARDS FIBRE FORMATIONS, INC.
K781388 08/21/1978 F.A. MOUNTING MEDIUM FLOW LABORATORIES, INC.
K781391 08/21/1978 PBS FOR FA (46-991-49) FLOW LABORATORIES, INC.
K781344 08/21/1978 OPTION PHO/SONIC B-MODE SCANNER G.D. SEARLE AND CO.
K780906 08/10/1978 AIR-FLO ALTERNATING PRESSURE PAD SYSTEM GAYMAR INDUSTRIES, INC.
K781372 08/21/1978 LIQUID T.B.C. MEDIUM GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780883 08/10/1978 E-Z-JECTOR HARCO PRODUCTS
K780884 08/10/1978 HYPO-GRIP HARCO PRODUCTS
K781132 08/10/1978 CHEMLAR HI CHEM, INC.
K781236 08/31/1978 ENTEROTUBE II HOFFMANN-LA ROCHE, INC.
K780905 08/14/1978 LIMB COVER HYDRO-MED PRODUCTS, INC.
K781225 08/31/1978 GLOBULIN TEST, HUMAN THYROXINE BINDING HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K781023 08/14/1978 ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU ICL SCIENTIFIC
K781017 08/14/1978 ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) ICL SCIENTIFIC
K781022 08/14/1978 ANTI-HUMAN CIQ SERUM ICL SCIENTIFIC
K781015 08/14/1978 ANTI-HUMAN LDL SERUM ICL SCIENTIFIC
K781026 08/10/1978 ANTITHROMBIN III SERUM, ANTI-HUMAN ICL SCIENTIFIC
K781016 08/14/1978 C3PA (GBG) PROPERDIN FACTOR B ICL SCIENTIFIC
K781024 08/14/1978 CERUOPLASMIN SERUM ANTI-HUMAN ICL SCIENTIFIC
K781408 08/21/1978 RID SYSTEM-(ACP) TEST ICL SCIENTIFIC
K781171 08/10/1978 INFUSION PUMP, PEDIATRIC MODEL 301 IMED CORP.
K781395 08/31/1978 DISPOSABLE AEROSOL "T" BRIGGS ADAPTOR INHAL-O-TECH MEDICAL PLASTIC
K781349 08/31/1978 PACER-TRACER PULSE WIDTH INSTROMEDIX, INC.
K781221 08/23/1978 DILUTION KIT, THERMAL, COLD PAC INSTRUMENTATION LABORATORY CO.
K781240 08/17/1978 ENZYMATIC TRIGLYCERIDES REAGENT KIT J.T. BAKER CHEMICAL CO.
K780896 08/23/1978 NEEDLES, DESIGN CHANGE, IV CATHETERS JELCO LABORATORIES
K781076 08/14/1978 CHEMISTRY ANALYZER JOHNS SCIENTIFIC, INC.
K781011 08/17/1978 K-Z CONCENTRATE K-ZYME LABS, INC.
K781019 08/14/1978 SURG. GOWN & DRAPE, LOW LINT TREATMENT KIMBERLY-CLARK CORP.
K781242 08/21/1978 ALLOY, AMALGAM, DISP. CAPSULE LEE PHARMACEUTICALS
K780966 08/21/1978 LEE-ALLOY DISPOSABLE CAPSULES LEE PHARMACEUTICALS
K781339 08/15/1978 ENDOTRACHEAL TUBE LIFE-LINE PRODUCTS, INC.
K781114 08/14/1978 ULTRAMATE 990 LITTON DENTAL PRODUCTS
K781234 08/10/1978 TUBES, LUKENS, TOMAS LUDWIG MEDICAL, INC.
K781128 08/10/1978 LDH (UV KINETIC) MACOMB CHEMICAL CO.
K781334 08/17/1978 DISPOSABLE SYRINGE FILL TUBE MALLINCKRODT GROUP, INC.
K781062 08/14/1978 DROPPER, SOLUTION TRICHROME, CEPTI-SEAL MARION LABORATORIES, INC.
K781061 08/14/1978 DROPPERS, SOLUTION, IODINE MARION LABORATORIES, INC.
K781356 08/21/1978 IMPLANT, EYE SPHERE MCGHAN MEDICAL CORP.
K780632 08/14/1978 MAXICEPTOR MED GENERAL
K780548 08/21/1978 DISPOSA-LOOPS MEDI-SPEC
K781110 08/18/1978 BANDAGE, COMPRESSION, FISTULAID MEDICAL DEVICE LABORATORIES
K781148 08/31/1978 ELECTROSURGICAL PENCIL SYSTEM MEDICAL PLASTICS, INC.
K780952 08/31/1978 MODEL 1812 CONTROL CONSOLE, ACCESSORIEX MEDTRONIC VASCULAR
K780953 08/31/1978 MODEL 1861 BLOOD PUMP MEDTRONIC VASCULAR
K781384 08/21/1978 WRIGHT RAPID STAIN MFG CHEMISTS, INC.
K781274 08/10/1978 GAMMA MED II MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K781143 08/14/1978 IMMUNOFLUORESCENCE TEST KIT MICROBIOLOGICAL ASSOC.
K781086 08/14/1978 INSULIN AUTOPAK MICROMEDIC SYSTEMS
K781180 08/14/1978 CLINIRIA T-3 UPTAKE TEST MILES LABORATORIES, INC.
K781181 08/14/1978 CLINIRIA TOTAL T-4 (RIA) TEST MILES LABORATORIES, INC.
K781108 08/31/1978 MICROCULT-GC CULTURE TEST MILES LABORATORIES, INC.
K780949 08/14/1978 BIO-MONITOR AMIKACIN MONITOR SCIENCE CORP.
K780951 08/14/1978 BIO-MONITOR GENTAMICIN MONITOR SCIENCE CORP.
K780950 08/14/1978 BIO-MONITOR TOBRAMYCIN MONITOR SCIENCE CORP.
K781219 08/31/1978 ECON-O2 MOUNTAIN MEDICAL EQUIPMENT, INC.
K781216 08/10/1978 INFUSION CONTROLLER, PARENTERAL NATIONAL PATENT DEVELOPMENT CORP.
K781154 08/10/1978 SYRINGE, INSULIN, HYPOTIP NATIONAL PATENT DEVELOPMENT CORP.
K780992 08/17/1978 MILLARD MOUTH GAG NESTOR ENGINEERING ASSOCIATES, INC.
K781275 08/31/1978 CHLORIDE/CARBON DIOXIDE REAGENT SET NOBEL SCIENTIFIC INDUSTRIES, INC.
K781296 08/31/1978 THYRO-SHURE NUCLEAR MEDICAL LABORATORIES, INC.
K780972 08/14/1978 QUICKRATE REACTION RATE ANALYZER OLYMPUS CORP.
K781335 08/31/1978 DIGOXIN RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781104 08/10/1978 PLASMA COAGULATION CONT., ABNORMAL ORTHO DIAGNOSTICS, INC.
K781129 08/31/1978 ACCESSORY TO 4-24 RECORDER OXFORD MEDILOG, INC.
K781130 08/23/1978 ACCESSORY TO ECG ANALYSIS SYS. OXFORD MEDILOG, INC.
K781134 08/17/1978 CATHETER, THERMAL DILUTION FIBEROPTIC OXIMETRIX, INC.
K781209 08/14/1978 MONITOR, OXYGEN, MODEL 3000A OXYAIR ENGINEERING, INC.
K780889 08/14/1978 DIGOXIN STANDARDS IN HUMAN SERUM PCL-RIA, INC.
K781284 08/31/1978 RABBIT ANTIBODY TO HUMAN T3 PCL-RIA, INC.
K781070 08/10/1978 SECOND ANTIBODY PCL-RIA, INC.
K781071 08/14/1978 STANDARDS, HORMONE, THYROID STIMULATING PCL-RIA, INC.
K781069 08/14/1978 T3 STANDARDS IN HUMAN SERUM PCL-RIA, INC.
K780981 08/02/1978 PORTABLE PNEUMATIC CALIBRATOR 65-150 PENNWALT CORP.
K781052 08/02/1978 CONTINUOUS EPIDURAL ANESTHESIA TRAY PORTEX, INC.
K781172 08/31/1978 U-DRAPE, BOUNDARY PROCTER & GAMBLE MFG. CO.
K781056 08/14/1978 DIGITAL IMAGE MEMORY/PROCESSOR QUANTEX CORP.
K781038 08/14/1978 HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM QUINTON, INC.
K780845 08/14/1978 CONCHANEOPAK A CARTRIDGE HUMIDIFIER RESPIRATORY CARE, INC.
K781106 08/10/1978 THERMOMETER, EXACTA TEMP S.M.B. CELSIUS CO., INC.
K780937 08/31/1978 MODEL 20 DIGITAL PULSE RATE MONITOR SENTRONIX, INC.
K781285 08/14/1978 INSULIN RIA KIT SERONO LABORATORIES, INC.
K781060 08/14/1978 MONOJECT ENDOSSEOUS DENTAL IMPLANT SHERWOOD MEDICAL INDUSTRIES
K781365 08/14/1978 SPARTA BRONCHIAL BRUSH SPARTA INSTRUMENT CORP.
K781047 08/18/1978 DRAPE, SURGICAL-SPARTAN LIMB SHEET SPARTAN HEALTHCARE PRODUCTS CO.
K781046 08/18/1978 IMPERVIOUS STOCKINET SPARTAN HEALTHCARE PRODUCTS CO.
K781302 08/15/1978 NEUROSTAT, LLOYD SPEMBLY MEDICAL LTD.
K781301 08/10/1978 WRAP, STERILIZATION STANFORD PROFESSIONAL PRODUCTS
K781281 08/21/1978 CEMENT, DENTAL/CAVITY LINER STAR DENTAL MFG. CO.
K781133 08/14/1978 PC-CALIBRATOR STRECK LABORATORIES, INC.
K780843 08/14/1978 BARRIER ABDOMINAL PACK FABRIC 450 SURGIKOS, INC.
K780842 08/14/1978 BARRIER BASIC PACK FABRIC 450 SURGIKOS, INC.
K780856 08/14/1978 BARRIER GYNECOLOGY PACK FABRIC 450 SURGIKOS, INC.
K780840 08/14/1978 BARRIER LAPAROTOMY SHEET 450 SURGIKOS, INC.
K780841 08/14/1978 BARRIER MEDIUM SHEET 450 SURGIKOS, INC.
K780844 08/14/1978 BARRIER OBSTETRICAL PACK FABRIC 450 SURGIKOS, INC.
K780839 08/14/1978 BARRIER PEDIATRIC/INCISE DRAPE 450 SURGIKOS, INC.
K781398 08/23/1978 TECA VS6 VIDEO STIMULATOR TECA, INC.
K780862 08/14/1978 MODEL 290 OXYGEN RICH AIR SUPPLY UNIT THE JOHN BUNN CO.
K780863 08/21/1978 MODEL 65 HIGH & LOW PRESSURE ALARM THE JOHN BUNN CO.
K780680 08/08/1978 UNIT, SPECTRA, CORRECTED, DIFFERENTIAL THE PERKIN-ELMER CORP.
K781293 08/18/1978 RESTORATIVE SYSTEM PROFILE THE S. S. WHITE CO.
K780861 08/10/1978 ELECTRONIC CLINICAL THERMOMETER TREND MEDICAL, INC.
K781439 08/31/1978 HEARING AID, UNITRON MODEL 958 UNITRON INDUSTRIES, INC.
K781434 08/31/1978 HEARING AID, UNITRON MODEL 975 UNITRON INDUSTRIES, INC.
K781189 08/10/1978 FLU VEN 0151 VENOSPITAL, INC.
K781185 08/10/1978 INFUSION SET W/ INJECTION SITE VENOSPITAL, INC.
K781187 08/10/1978 INFUSION SET W/ INJECTION SITE, 23D-W VENOSPITAL, INC.
K781184 08/10/1978 INFUSION SET, VENOTHIN 19 VENOSPITAL, INC.
K781190 08/10/1978 INFUSION SET, VENOTHIN 21 VENOSPITAL, INC.
K781188 08/10/1978 INFUSION SET, VENOTHIN 25 VENOSPITAL, INC.
K781186 08/10/1978 INFUSION, VENOTHIN 23 VENOSPITAL, INC.
K781168 08/31/1978 GENERATOR, PULSE, PACEMAKER VITATRON MEDICAL BV
K781322 08/17/1978 STERILE WET DRESSING PACK W.G. WHITNEY CORP.
K781342 08/31/1978 GLUCOSE TEST WAKO INTL., INC.
K780932 08/31/1978 MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT WESTERN LABORATORIES CORP.
K780850 08/23/1978 SEARLE NEONATAL OXYGEN PROBE WILL ROSS CO.
K781257 08/14/1978 VENTILATION TUBE SILI. SHEPPARD TYPE XOMED, INC.
K781260 08/14/1978 VENTILATION TUBE SILICONE PAPARELLA TYPE XOMED, INC.
K781259 08/14/1978 VENTILATION TUBE TEFLON SHEPARD TYPE XOMED, INC.
K781258 08/14/1978 VENTILATION TUBE. SILI. DONALDSON TYPE XOMED, INC.
K781418 08/31/1978 XOMED TRANSSPHENOIDAL HANDPIECE XOMED, INC.
K781074 08/31/1978 OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 XORBOX
K781312 08/10/1978 THERMOMETER, MODEL 49TA YELLOW SPRINGS INSTRUMENT CO., INC.
K781403 08/21/1978 FTA-ABS TEST SYSTEM ZEUS SCIENTIFIC, INC.


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