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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C (K770012)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
CHEMISTRY CONTROL-LOW & HIGH TQC TM (K770380)Technicon Instruments Corp.1977-04-15
METER, PH, DIGITAL, MODEL 3560 (K770347)Beckman Instruments, Inc.1977-04-15
DP-5000 DATA REDUCTION SYSTEM (K770572)Beckman Instruments, Inc.1977-04-15
ACA LIPASE ANALYTICAL TEST PACK (K770364)E.I. Dupont DE Nemours & Co., Inc.1977-04-15
BLOOD GAS ANALYZER-CALIBRATION GAS (K770494)Gardner Cryogenics1977-04-15
DIGITAL SCANNER (K770526)The Perkin-Elmer Corp.1977-04-08
METER, IV PH, MODEL EXPANDOMATIC (K770352)Beckman Instruments, Inc.1977-04-08
SPECTROPHOTOMETER ANALYSIS SYS., AA-175 (K770443)Varian Assoc., Inc.1977-04-08
ACA AMMONIA ANALYTICAL TEST PACK (K770363)E.I. Dupont DE Nemours & Co., Inc.1977-04-08
SPECTROPHOTOMETER ANALYSIS SYS., AA-375 (K770444)Varian Assoc., Inc.1977-04-08
RIA-DAC TM HTSH KIH (K770604)Mallinckrodt Critical Care1977-04-06
MINICON (K770398)Amicon, Inc.1977-04-06
IN VITRO T-3 UPTAKE TEST (K770480)Clinical Assays, Inc.1977-04-06
REAGENT LDH-L, ENZYME (K770313)Icn Pharmaceuticals, Inc.1977-04-05
ANALYZER, 751 KINETIC/ENDPOINT (K770306)Sclavo, Inc.1977-04-05
MICRO/PETTOR, SMI (K770307)Lederle Laboratories1977-04-05
CHEMISTRY CONTROL, NORMAL (K770310)Icn Pharmaceuticals, Inc.1977-04-05
REAGENT CPK, ENZYME (K770319)Icn Pharmaceuticals, Inc.1977-04-05
BUN, ENZYMATIC (K770315)Icn Pharmaceuticals, Inc.1977-04-05
T3 RIA (PEG) DIAGNOSTIC KIT (K770201)Abbott Laboratories1977-04-05
METER, IV PH, MODEL ZEROMATIC (K770351)Beckman Instruments, Inc.1977-04-05
REAGENT GOT, ENZYME (K770318)Icn Pharmaceuticals, Inc.1977-04-05
CHEMISTRY CONTROL, ABNORMAL (K770312)Icn Pharmaceuticals, Inc.1977-04-05
ALKALINE PHOSPHATASE ENZYMATIC (K770316)Icn Pharmaceuticals, Inc.1977-03-30
GLUCOSE TRINDER, ENZYMATIC (K770317)Icn Pharmaceuticals, Inc.1977-03-30
REAGENT GPT, ENZYME (K770314)Icn Pharmaceuticals, Inc.1977-03-30
GLUCOSE REAGENT, ENZYMATIC (K770311)Icn Pharmaceuticals, Inc.1977-03-30
SERI-SEP (K770107)Torval Corp.1977-03-22
MEGA-DIASTIX (K761310)Miles Laboratories, Inc.1977-03-21
MT II SYSTEM - SERUM ALBUMIN (K761329)Technicon Instruments Corp.1977-03-21
VITAMIN B12 RADIOASSAY (K761321)Kallestad Laboratories, Inc.1977-03-21
CLINILAB AUTOMATED URINALYSIS SYSTEM (K761306)Miles Laboratories, Inc.1977-03-21
CHEMSTRIP G (K770271)Boehringer Mannheim Corp.1977-03-16
CENTRIA T4 RIA (K761272)Clinical Diagnostics, Inc.1977-03-16
SPECTROPHOTOMETERS, INFRARED MODELS X99 (K770278)The Perkin-Elmer Corp.1977-03-10
SPECTROPHOTOMETER, MODEL 597 IR (K770288)The Perkin-Elmer Corp.1977-03-10
PIPETTOR W/DETIPPER (K770355)Sherwood Medical Industries1977-03-08
CHOLESTEROL STANDARDS (K770277)Worthington Biochemical Corp.1977-03-01
TEST, AMMONIA, BMC REAGENTSET (K770273)Boehringer Mannheim Corp.1977-03-01
AUTO-ENZYMATIC GLUCOSE (K770229)Harleco1977-03-01
PIPETTOR, 400, CENTRIFICHEM SYSTEM (K770193)Universal Instruments Corp.1977-03-01
URIC ACID TEST, BMC AUTOFLO (K770272)Boehringer Mannheim Corp.1977-03-01
MOTORIZED OPERATOR FOR PIPETTING DEV. (K770208)Kensington Scientific1977-02-28
LC-65T DETECTOR AND OVEN (K770255)The Perkin-Elmer Corp.1977-02-25
CHOLESTEROL TEST (K770265)Sclavo, Inc.1977-02-25
CHROMATOGRAPH, SERIES 3, LIQUID (K770254)The Perkin-Elmer Corp.1977-02-24
ALKALINE PHOSPHATASE (ALP)/PNPP (K761315)Princeton Biomedix1977-02-24
TRI-CON TRIGLYCERIDGE REAGENTS (K761283)Dade, Baxter Travenol Diagnostics, Inc.1977-02-24
COMPU-PET 300 (K761290)Nuclear Medical Laboratories, Inc.1977-02-24
LDH-L TEST (K770267)Sclavo, Inc.1977-02-23
GO/HPO-GLUCOSE REAGENT (TRINDER) (K770200)Beckman Instruments, Inc.1977-02-23
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY (K770262)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-02-23
REAGENT SYSTEM (K770242)American Monitor Corp.1977-02-22
GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 (K770025)The Perkin-Elmer Corp.1977-02-16
NEONATAL T4 RIA KIT (K770241)Diagnostic Products Corp.1977-02-14
URIN. L7-OH CORTICOSTEROID T(NON HYDRO) (K761271)Eppendorf-Brinkmann, Inc.1977-02-14
AUTO CREATININE REAGENT (GILFORD 3400-E) (K761280)Harleco1977-02-14
GAMMA 4000 SCINTILLATION COUNTER (K770088)Beckman Instruments, Inc.1977-02-14
ANALYTIX AUTO SAMPLE PREP. STA. 1600 (K770210)G.D. Searle and Co.1977-02-14
REFLOMAT/REFLOTEST SYSTEM (K761148)Boehringer Mannheim Corp.1977-02-11
SMA REFERENCE SERUM 3 (K770142)Technicon Instruments Corp.1977-02-11
AUTO CREATININE REAGENT (ABBOTT SYSTEM) (K761279)Harleco1977-02-11
DATA-TOPE T3 UPTAKE PROCEDURE (K761281)Dade, Baxter Travenol Diagnostics, Inc.1977-02-09
SPAC TM T4 RIA KIT (K770156)Mallinckrodt Critical Care1977-02-07
SPAC TM T3 UPTAKE KIT (K770033)Mallinckrodt Critical Care1977-02-07
ABSORPTION SPECTROPHOTOMETERS (K761316)The Perkin-Elmer Corp.1977-02-07
L080 SERIES LIQUID CHROMATOGRAPH (K761351)Hewlett-Packard Co.1977-02-02
SMA MICROLYZER (K761342)Technicon Instruments Corp.1977-02-01
SERIES II LIQUID CHROMATOGRAPH (K761219)The Perkin-Elmer Corp.1977-02-01
MANUEL BILIRUBIN REAGENT SET (K770121)Harleco1977-01-31
ALKALINE PHOSPHATASE ISOYZME REAGENT SET (K770155)Gelman Instrument Co.1977-01-31
MICRO-MIX PIPETTE SHAKER (K770165)Maddak, Inc.1977-01-31
CENTRIFICHEM 200MG/DL CHOL. CAL. STD. (K770127)Union Carbide Corp.1977-01-31
CENTRIFICHEM CHOLES. CALIB. STD. SET (K770126)Union Carbide Corp.1977-01-31
FLOUROMETER/DENSITOMETER MODEL 720 (K770026)Corning Medical & Scientific1977-01-26
LDH ISOTROL T (K770049)Sigma Chemical Co.1977-01-26
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT (K761136)Beckman Instruments, Inc.1977-01-26
BIO TROL-T TRIOLEIN SOLUTIONS (K770072)Boehringer Mannheim Corp.1977-01-26
PIPETTING DEVICES (K770013)Kensington Scientific1977-01-25
GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT (K761089)Beckman Instruments, Inc.1977-01-25
GLUCOSE KIT (K761320)Environmental Chemical Specialties1977-01-25
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 (K761061)Beckman Instruments, Inc.1977-01-25
GLUCOSE ANALYZER 2 (K761060)Beckman Instruments, Inc.1977-01-25
ENIT ABA THYROXINE ASSAY (K770070)Syva Co.1977-01-21
GP3%SP-2100DOHON100/120 MESH SUPELCOPORT (K761226)Supelco, Inc.1977-01-14
PH/BLOOD GAS SYSTEM (K760969)Instrumentation Laboratory CO1977-01-12
REAGENTS (K761086)Simmler & Son, Inc.1977-01-12
WEIL ONCOMETER (IL 186) (K760975)Instrumentation Laboratory CO1977-01-12
SODIUM CITRATE (K761177)Bio/Data Corp.1977-01-10
AQUAMATIC K-MODULE MODEL K-10 (K761337)Gorman Rupp Industries1977-01-10
RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) (K761346)New England Nuclear1977-01-07
ENZYMATIC LIPASE MAX-PACK REAGENT (K760786)Calbiochem1977-01-06
DYNAZYME-II TM LDH-L 340 KIT (K761343)J.T. Baker Chemical Co.1977-01-05
DYNAZYME-II TM CK-230 KIT (K761344)J.T. Baker Chemical Co.1977-01-05
GLUCO-HEX TM REAGENT KIT (K761345)J.T. Baker Chemical Co.1977-01-05
ANGIOTENSIN I IMMUTOPE KIT (K761267)Squibb & Sons, Inc.1976-12-30
DATA-TOPE T4 RIA PROCEDURE (K761282)Dade, Baxter Travenol Diagnostics, Inc.1976-12-30
CENTRIA T3 RIA (K761305)Union Carbide Corp.1976-12-30
OB-GYN CONTROL SERA (CODE 196300) (K761309)Amersham Corp.1976-12-30
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