FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K770822 |
07/11/1977 |
A-GENT ALBUMIN |
ABBOTT LABORATORIES |
|
K770594 |
07/06/1977 |
LABORATORY EXPENDABLE PRODUCTS |
ABCO DEALERS, INC. |
|
K771134 |
07/05/1977 |
ANESTHESIA BREATHING CIRCUIT |
AIR PRODUCTS & CHEMICALS, INC. |
|
K770873 |
07/11/1977 |
CIRCUMCISION KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K771050 |
07/14/1977 |
HYPERALIMENTATION TRAY |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K771024 |
07/15/1977 |
CHOLINESTERASE REAGENT SYSTEM |
AMERICAN MONITOR CORP. |
|
K770909 |
07/14/1977 |
ENZYMATIC CHOLESTEROL REAGENT SET |
AMERICAN MONITOR CORP. |
|
K770824 |
07/15/1977 |
FLAME PHOTOMETER MOLEL 4600, KDA |
AMERICAN MONITOR CORP. |
|
K771262 |
07/21/1977 |
PACEMAKER & CARDIAC LEAD, BIPOLAR |
ARCO MEDICAL PRODUCTS CO. |
|
K771096 |
07/01/1977 |
TELHTHERAPY SIMULATOR AECL-CP, G-3200 |
ATOMIC ENERGY OF CANADA |
|
K770983 |
07/29/1977 |
CATHETER THORACIC, AXIOM |
AXIOM MEDICAL, INC. |
|
K771048 |
07/19/1977 |
CATHETERS, DRAINAGE |
AXIOM MEDICAL, INC. |
|
K770652 |
07/06/1977 |
FLUORESCENCE ILLUMINATOR ACCESSORY |
BAUSCH & LOMB, INC. |
|
K770722 |
07/11/1977 |
THROMBO SCREEN QUANTITATIVE HEPARIN ASSA |
BAY AREA HEMA. ONCO. CLINIC. & RES. L |
|
K770980 |
07/11/1977 |
EMATOLOGY DILUENT RESERVOIR CLOSURE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K771058 |
07/01/1977 |
EPTONE BACK-UP BROTH, VACUTAINER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K771061 |
07/05/1977 |
ODUFLEX AEROSOL SET |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K770877 |
07/21/1977 |
DATA REDUCTION SYSTEM, DP-3000 |
BECKMAN INSTRUMENTS, INC. |
|
K770948 |
07/15/1977 |
LIPOPROTEIN PROFILING SYSTEM |
BECKMAN INSTRUMENTS, INC. |
|
K770750 |
07/05/1977 |
REAGENT KIT, ENZYMATIC AMYLASE |
BECKMAN INSTRUMENTS, INC. |
|
K770825 |
07/11/1977 |
SPECTROPHOTOMETERS,34,35,36,3600 |
BECKMAN INSTRUMENTS, INC. |
|
K771135 |
07/14/1977 |
QUANTIMUNE NEONATAL & THYROXINE RIA |
BIO-RAD |
|
K770774 |
07/11/1977 |
LYTETEK SYSTEM |
BOEHRINGER MANNHEIM CORP. |
|
K771254 |
07/15/1977 |
ACCU. CROWN COLD CURE |
BRIAR CLIFF, INC. |
|
K771139 |
07/14/1977 |
CRP-WELLCOTEST |
BURROUGHS WELLCOME CO. |
|
K771149 |
07/27/1977 |
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 |
C.R. BARD, INC. |
|
K770953 |
07/14/1977 |
MONITOR, AERATION, TEC-TEST |
CASTLE CO. |
|
K771028 |
07/05/1977 |
ANALYZER, OXYGEN, MODEL OM-92 |
CAVITRON CORP. |
|
K770900 |
07/21/1977 |
CAST BRWM, FRACTURE |
CHASE MFG. CO. |
|
K770898 |
07/21/1977 |
FRACTURE CAST BRACE KIT, PLASTIC |
CHASE MFG. CO. |
|
K770899 |
07/21/1977 |
FRACTURE CAST BRACE, POLY |
CHASE MFG. CO. |
|
K770723 |
07/11/1977 |
TABLE, TREATMENT, THERAPY, PHYSICAL |
CHATTANOOGA PHARMACAL CO. |
|
K770724 |
07/11/1977 |
TRACTION DEVICES, INTERMITTENT, TX |
CHATTANOOGA PHARMACAL CO. |
|
K770780 |
07/11/1977 |
REAGENTS |
CHEMETRICS CORP. |
|
K771118 |
07/11/1977 |
CENTRIA SEPARATION COLUMNS TYPE A |
CLINICAL DIAGNOSTICS, INC. |
|
K771015 |
07/11/1977 |
VYGON RED-O-PACK |
COASTAL BEND MEDICAL PRODUCTS, INC. |
|
K770852 |
07/14/1977 |
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 |
CONCORD LABORATORIES, INC. |
|
K770851 |
07/14/1977 |
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 |
CONCORD LABORATORIES, INC. |
|
K770850 |
07/15/1977 |
TRAY, BLOOD GAS, ARTERIAL, #4014 |
CONCORD LABORATORIES, INC. |
|
K770792 |
07/05/1977 |
TUBE, STAIN, RETICULOCYTE, LARC |
CORNING MEDICAL & SCIENTIFIC |
|
K771070 |
07/14/1977 |
DRY HEAT STERILIZER |
CPAC, INC. |
|
K771071 |
07/14/1977 |
PORTO-VAC |
CPAC, INC. |
|
K770972 |
07/15/1977 |
CARDIOZYME CK-TOTAL REAGENTS |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
|
K771214 |
07/15/1977 |
SUPERFINE DIAMONDS |
DEN-MAT CORP. |
|
K771179 |
07/15/1977 |
BIOBOND MASTER STAIN AND GLAZE KIT |
DENTSPLY INTL. |
|
K771009 |
07/13/1977 |
ELECTRO-SURGICAL DEVICES |
DESERET PHARMACEUTICAL CO. |
|
K771097 |
07/14/1977 |
FORCEP, DISP., A CLAMP |
DRAVON MEDICAL, INC. |
|
K770730 |
07/11/1977 |
PUMP, INFUSION, DYNATECH/HANDLEY |
DYNATECH MEDICAL PRODUCTS |
|
K771142 |
07/14/1977 |
T3 CLASP RIA KIT |
E. R. SQUIBB & SONS, INC. |
|
K771233 |
07/15/1977 |
PHENYTOIN ANALYTICAL TEST PACKS |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771223 |
07/14/1977 |
GRAY TONE IMAGING FILM |
EASTMAN KODAK COMPANY |
|
K771190 |
07/11/1977 |
ABRAMSON TRACHEA HOOK & RETRACTOR |
EDWARD WECK, INC. |
|
K771187 |
07/11/1977 |
DERMAHOOK #382-805 |
EDWARD WECK, INC. |
|
K771191 |
07/11/1977 |
HEISS RETRACTOR |
EDWARD WECK, INC. |
|
K771189 |
07/11/1977 |
HOT TEMP CAUTERY |
EDWARD WECK, INC. |
|
K771192 |
07/11/1977 |
LOWMAN BONE FORCEP |
EDWARD WECK, INC. |
|
K771186 |
07/15/1977 |
MICRO BI-POLAR FORCEPS #39-200 |
EDWARD WECK, INC. |
|
K770686 |
07/14/1977 |
THERATHERM |
ELECTRO THERAPEUTIC DEVICES, INC. |
|
K771013 |
07/01/1977 |
MOSQUITO |
EMDE CORP. |
|
K771067 |
07/21/1977 |
CHOLESTEROL KIT |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K771068 |
07/12/1977 |
TRIGLYCERIDE KIT |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K771119 |
07/15/1977 |
PASTES, RESTORATIVE & TINTED, DEBTAL |
ESPE DENTAL PRODUCTS |
|
K771057 |
07/05/1977 |
ANESTHESIA MACHINE |
FOREGGER |
|
K771287 |
07/21/1977 |
FINGEO EXTENSION SPLINTS |
FRED SAMMONS, INC. |
|
K771288 |
07/21/1977 |
JAMAR DYNAMOMETEO BK-7498 |
FRED SAMMONS, INC. |
|
K771274 |
07/21/1977 |
QUADRIPLEGIC MEAT KNIFE |
FRED SAMMONS, INC. |
|
K770773 |
07/11/1977 |
PIPETTE, DILUTING, MODEL ADP-30SD |
G.D. SEARLE AND CO. |
|
K770772 |
07/11/1977 |
PIPETTE, DISPENSING, MODEL ADP-30SD |
G.D. SEARLE AND CO. |
|
K771238 |
07/15/1977 |
RID PLATES & INTENSI. FOR HUMAN IGE ETC |
G.D. SEARLE AND CO. |
|
K771083 |
07/21/1977 |
SEQUENTIAL PRESSURE CUFF |
GAYMAR INDUSTRIES, INC. |
|
K770680 |
07/01/1977 |
HEMATRAK |
GEOMETRIC DATA, DIV. SMITHKLINE CORP. |
|
K771062 |
07/14/1977 |
EBV TEST |
GULL LABORATORIES, INC. |
|
K771063 |
07/11/1977 |
HSV TEST |
GULL LABORATORIES, INC. |
|
K770944 |
07/27/1977 |
INSTATEMP |
H.I. SILVERMAN, D.SC. |
|
K771018 |
07/14/1977 |
TRANS 2000 |
HAMILTON INDUSTRIES, INC. |
|
K770887 |
07/14/1977 |
AUTO TOTAL PROTEIN FOR ANALYZER |
HARLECO |
|
K770886 |
07/14/1977 |
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER |
HARLECO |
|
K771131 |
07/21/1977 |
CLINICARD UV AMYLASE CHEMISTRY |
HARLECO |
|
K770816 |
07/11/1977 |
ULTRACHEM ALBUMIN |
HARLECO |
|
K770817 |
07/11/1977 |
ULTRACHEM CALCIUM |
HARLECO |
|
K770819 |
07/11/1977 |
ULTRACHEM CREATININE |
HARLECO |
|
K770820 |
07/11/1977 |
ULTRACHEM INORGANIC PHOSPHORUS |
HARLECO |
|
K770870 |
07/14/1977 |
ULTRAZYME PLUS ALP |
HARLECO |
|
K770883 |
07/14/1977 |
ULTRAZYME PLUS GOT |
HARLECO |
|
K770882 |
07/14/1977 |
ULTRAZYME PLUS GPT |
HARLECO |
|
K770815 |
07/11/1977 |
ULTRAZYME PLUS GT |
HARLECO |
|
K770871 |
07/14/1977 |
ULTRAZYME PLUS HBD |
HARLECO |
|
K770818 |
07/11/1977 |
ULTRAZYME PLUS, LDH |
HARLECO |
|
K771094 |
07/21/1977 |
UNIPAK ALBUMIN |
HARLECO |
|
K771087 |
07/21/1977 |
UNIPAK BUN |
HARLECO |
|
K771093 |
07/21/1977 |
UNIPAK CHOLESTEROL |
HARLECO |
|
K771091 |
07/21/1977 |
UNIPAK GLUCOSE |
HARLECO |
|
K771090 |
07/11/1977 |
UNIPAK HEMOGLOBIN |
HARLECO |
|
K771092 |
07/21/1977 |
UNIPAK TOTAL & DIRECT BILIRUBIN |
HARLECO |
|
K771089 |
07/21/1977 |
UNIPAK TOTAL BILIRUBIN |
HARLECO |
|
K771088 |
07/21/1977 |
UNIPAK URIC ACID |
HARLECO |
|
K770694 |
07/01/1977 |
CPK ULTRAZYME PLUS |
HARLECO DIAGNOSTICS |
|
K771357 |
07/29/1977 |
GROUP AUDITORY TRAINER HC 431R |
HC ELECTRONICS |
|
K771356 |
07/29/1977 |
POST-AURICULAR HEARING AID HC 880 |
HC ELECTRONICS |
|
K770830 |
07/11/1977 |
PLATELET AGITATOR |
HELMER LABS, INC. |
|
K771000 |
07/15/1977 |
TRENDAR |
HI CHEM, INC. |
|
K771105 |
07/05/1977 |
NEBULIZER, MOLEL 503, PART #17068 |
HOSPAL MEDICAL CORP. |
|
K771110 |
07/15/1977 |
HERITAGE SPECIAL ALLOY |
HOWMEDICA CORP. |
|
K770690 |
07/21/1977 |
MASK, VAPOR, MONOMER |
HOWMEDICA CORP. |
|
K770982 |
07/15/1977 |
UNITED SKIN BARRIER |
HOWMEDICA CORP. |
|
K771185 |
07/15/1977 |
PERIODONTIC TOOTHBRUSH, #0126-0190-00 |
HOYT LABORATORIES |
|
K771184 |
07/15/1977 |
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 |
HOYT LABORATORIES |
|
K771183 |
07/15/1977 |
TOOTHBRUSH, PEDODONTIC, #0126-0188-00 |
HOYT LABORATORIES |
|
K771107 |
07/11/1977 |
COUNTER 700 & HC-700 HEMO 0 REF. |
HYCEL, INC. |
|
K771154 |
07/21/1977 |
CPK-INT TEST |
HYCEL, INC. |
|
K770803 |
07/05/1977 |
HEMOTOLOGY PRODU&TS (5 IN ALL) |
HYCEL, INC. |
|
K771226 |
07/21/1977 |
LAS-R TEST PROGRAM |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771044 |
07/15/1977 |
TMA BICARBONATE DILUENT |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K770438 |
07/01/1977 |
CART, PROCEDURES |
I E INDUSTRIES |
|
K771080 |
07/14/1977 |
STEAM STERILIZATION INDICATOR |
INFO-CHEM |
|
K770946 |
07/05/1977 |
RECORD, MODEL 702, I.L. |
INSTRUMENTATION LABORATORY CO. |
|
K771257 |
07/15/1977 |
ACRY TEMP |
INTERSTATE DENTAL CO., INC. |
|
K771248 |
07/15/1977 |
SILICONE IMPRESSION MATEOIAL |
INTERSTATE DENTAL CO., INC. |
|
K770664 |
07/05/1977 |
NEBULIZER |
J & S INDUSTRIES, INC. |
|
K771344 |
07/27/1977 |
GUSBERG HYSTERECTOMY CLAMP |
J. SKLAR MFG. CO., INC. |
|
K771060 |
07/21/1977 |
DIAG. CONDUCTA RATE BUN REAG. SET |
J.T. BAKER CHEMICAL CO. |
|
K771059 |
07/21/1977 |
DIAG. OZYRATE GLUCOSE REAG. SET |
J.T. BAKER CHEMICAL CO. |
|
K771108 |
07/29/1977 |
NEEDLE, CHIBA UNIVERSITY |
JOHANNAH MEDICAL SERVICES, INC. |
|
K771144 |
07/14/1977 |
RHODAMINE-CONJUGATED ANTISERUM |
KENT LABORATORIES, INC. |
|
K771252 |
07/15/1977 |
CB600, TURBINE CONTROL BOL |
LITTON DENTAL PRODUCTS |
|
K771251 |
07/15/1977 |
HU:500, HYGIENASSIST |
LITTON DENTAL PRODUCTS |
|
K770795 |
07/11/1977 |
SHAVE PREP SET |
LUKENS CORP. |
|
K770797 |
07/11/1977 |
TRAY, CATHETERIZATION W/FOLEY, STERILE |
LUKENS CORP. |
|
K771249 |
07/15/1977 |
JOY LIGHT |
M.D. INTL., INC. |
|
K770844 |
07/14/1977 |
FLUCOSE U.V. TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K771066 |
07/11/1977 |
CATHETER, SAMPLING, CONDUIT |
MENTOR CORP. |
|
K770764 |
07/21/1977 |
TISSUE CULTURE MEDIA W/HEPES BUFFER |
MICROBIOLOGICAL ASSOC. |
|
K771035 |
07/05/1977 |
CULTURE TEST FOR NEISSERIA GONORRHOEAE |
MILES LABORATORIES, INC. |
|
K770984 |
07/05/1977 |
TA-2 TEMPERATURE ALARM |
MISTOGEN EQUIPMENT CO. |
|
K771036 |
07/14/1977 |
SHAVE PREP TRAY |
PARKE-DAVIS CO. |
|
K771130 |
07/15/1977 |
DESENSITRON |
PARKER LABORATORIES, INC. |
|
K770942 |
07/21/1977 |
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
|
K771136 |
07/14/1977 |
SURGICAL HEAD DRAPE, DISP. |
PROCTER & GAMBLE MFG. CO. |
|
K771157 |
07/21/1977 |
RM VI-HV |
RICH-MAR CORP. |
|
K770517 |
07/15/1977 |
NF DEVICE |
RPR, INC. |
|
K770981 |
07/11/1977 |
LANCER CAPILLARY BLOOD SERUM SEPARATOR |
SHERWOOD MEDICAL INDUSTRIES |
|
K770902 |
07/14/1977 |
COLORIMETRIC DETERM. SOCITRATE DEHYDRO. |
SIGMA CHEMICAL CO. |
|
K770849 |
07/14/1977 |
VOLUMET INFUSION PUMP, MODIFI. OF |
SIGMAMOTOR, INC. |
|
K770767 |
07/05/1977 |
IN VITRO DIAG. FOR URIC ACID |
SMITH KLINE DIAGNOSTICS, INC. |
|
K771042 |
07/13/1977 |
INTRODUCER, CAT. #INT-05FR. |
SORENSEN RESEARCH |
|
K771041 |
07/13/1977 |
INTRODUCER, CAT. #INT-06FR. |
SORENSEN RESEARCH |
|
K771246 |
07/15/1977 |
ALARM SYS FOR NITROUS OXIDE SYS. |
STAR DENTAL MFG. CO. |
|
K771247 |
07/15/1977 |
CORE MATERIAL |
STAR DENTAL MFG. CO. |
|
K771128 |
07/15/1977 |
NEKO CERAMIC CONVENIENCE CROWNS |
STERNDENT CORP. |
|
K771200 |
07/21/1977 |
ORTHOSCOPE |
STRYKER CORP. |
|
K771199 |
07/25/1977 |
SURGIPULSE HEART RATE MONITOR |
STRYKER CORP. |
|
K771032 |
07/14/1977 |
POUCHES, PEEL OPEN, BREATHABLE |
SURGICOT, INC. |
|
K771188 |
07/14/1977 |
REVERSING CLICK GENERATOR RCG6 |
TECA, INC. |
|
K770695 |
07/14/1977 |
MONITOR, BED, TECHNOLICS |
TECHNOLICS, INC. |
|
K771206 |
07/15/1977 |
AV FISTULA NEEDLE SET |
TERUMO AMERICA, INC. |
|
K771203 |
07/14/1977 |
DISP. HYPODERMIC NEEDLE |
TERUMO AMERICA, INC. |
|
K771211 |
07/14/1977 |
DOPPLER (UTD-5 & UTD-6) |
TERUMO AMERICA, INC. |
|
K771205 |
07/14/1977 |
HYPODERMIC SYRINGE |
TERUMO AMERICA, INC. |
|
K771204 |
07/14/1977 |
SURFLO WINGED INFUSION SET |
TERUMO AMERICA, INC. |
|
K771209 |
07/26/1977 |
TERUFUSION BLOOD ADMIN. SET |
TERUMO AMERICA, INC. |
|
K771207 |
07/14/1977 |
TERUFUSION DONOR SET |
TERUMO AMERICA, INC. |
|
K771210 |
07/11/1977 |
UROGARD URINARY DRAINAGE BAG |
TERUMO AMERICA, INC. |
|
K770917 |
07/14/1977 |
GLUTAMATE OXALACETIC TRANSAMINASE |
THE DOW CHEMICAL CO. |
|
K771101 |
07/21/1977 |
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET |
THE DOW CHEMICAL CO. |
|
K770889 |
07/11/1977 |
BURN DRESSING KIT |
THE OWENBY CO. |
|
K770907 |
07/05/1977 |
SPIROMETEO EXHAUST |
TIMETER INSTRUMENT CORP. |
|
K771027 |
07/05/1977 |
ELECTROCARDIOGRAPHIC PATIENT CABLES |
TRONOMED, INC. |
|
K771216 |
07/21/1977 |
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET |
UNION CARBIDE CORP. |
|
K771215 |
07/21/1977 |
CENTRIFICHEM TRIGLYCERIDE CALI. STD. |
UNION CARBIDE CORP. |
|
K770841 |
07/14/1977 |
TRIGLYCERIDE ENZYMATIC METHOD |
UNION CARBIDE CORP. |
|
K770954 |
07/01/1977 |
UNIVUE I |
UNION CARBIDE CORP. |
|
K770827 |
07/21/1977 |
CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500 |
VARIAN ASSOC., INC. |
|
K771202 |
07/21/1977 |
WALPEO TABLH |
WALPEO CORP. |
|
K771181 |
07/14/1977 |
VAGINAL ILLUMINATOR, MODEL 78570 |
WELCH ALLYN, INC. |
|
K771132 |
07/14/1977 |
KENWOOD BIOLOGICAL STEOILIZ. INDICATOR |
WILL ROSS CO. |
|
K771145 |
07/15/1977 |
WILL-CERAM W-2 |
WILLIAMS GOLD REFINING CO., INC. |
|
K771143 |
07/11/1977 |
INORGANIC PHOSPHORUS STANDARDS |
WORTHINGTON BIOCHEMICAL CORP. |
|
K771001 |
07/11/1977 |
STATZYME GLUCOSE |
WORTHINGTON BIOCHEMICAL CORP. |
|
K770831 |
07/11/1977 |
STATZYME URIC ACID REAGENT |
WORTHINGTON BIOCHEMICAL CORP. |
|
K771106 |
07/01/1977 |
FORCEPS, OB, NON-COMPRESSIVE |
ZEPPELIN MEDIZINLECHNIK GMBH |
|