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Clinical Chemistry

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

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RecordFirmDate
TRIGLYCERIDES (LIPASE) REAGENT SET (K761262)Worthington Biochemical Corp.1976-12-29
AUTO-INORGANIC PHOSPHORUS REAGENT (K761238)Harleco1976-12-29
CHOLESTEROL AUTOMATED REAGENT (K761263)Worthington Biochemical Corp.1976-12-29
SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY (K760749)Gilford Instrument Laboratories, Inc.1976-12-29
AUTO-INORGANIC PHOSPHORUS REAGENT (K761239)Harleco1976-12-29
AUTO-ENZYMATIC GLUCOSE (K761240)Harleco1976-12-29
GEMENI GPT (ALT) ASSAY (K761269)Electro-Nucleonics Laboratories, Inc.1976-12-29
ENZYMATIC BUN (RATE) REAGENT KIT (K761261)Beckman Instruments, Inc.1976-12-29
CHOLESTEROL CALIBRATOR (K761197)Beckman Instruments, Inc.1976-12-21
CPK1SOENZYMES DETERMINATION PRO. #715-EP (K761212)Sigma Chemical Co.1976-12-21
ENZYMATIC TRIGLYCERIDES (END POINT) (K761200)Beckman Instruments, Inc.1976-12-21
ELECTROPHORESIS ACCESSORY MO. 3526 (K761248)Gilford Instrument Laboratories, Inc.1976-12-21
AUTO TOTAL BILIRUBIN REAGENT (K761218)Harleco1976-12-21
AUTO TOTAL PROTEIN (K761257)Harleco1976-12-21
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT (K760946)Schwarz Mann1976-12-21
AUTO TOTAL PROTEIN (K761217)Harleco1976-12-21
WELL COUNTERS, LOGIC II (200 SERIES) (K761214)Abbott Laboratories1976-12-16
MT II - TEST FOR CONTINUOUS FLOW ANAL (K761165)Technicon Instruments Corp.1976-12-13
GLUCOSE OXIDASE REAGENT SYSTEM (K761181)Nobel Scientific Industries, Inc.1976-12-13
MAX L SYSTEM (K761168)Brinkman Instruments, Inc.1976-12-10
URIC ACID REAGENT SET (K760989)Worthington Biochemical Corp.1976-12-09
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ (K761154)Advanced Biomedical Methods, Inc.1976-12-09
ANALYZER, PROGRAMMABLE DISCRETE (PDA) (K760642)Anatronics Corp.1976-12-09
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE (K761153)Advanced Biomedical Methods, Inc.1976-12-09
S-UREA-N, IN VITRO DIAG FOR BUN (K761152)Advanced Biomedical Methods, Inc.1976-12-09
RADIO IMMUNO ASSAY KIT/ (K760619)New England Nuclear1976-12-06
MULTI-CELL ULTRAFILTRATION SYSTEM (K761100)Amicon, Inc.1976-12-06
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE (K761090)Technicon Instruments Corp.1976-12-02
GAMMACORD II CALCULATOR INTERFACE (K761063)Miles Laboratories, Inc.1976-12-02
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN (K761027)Harleco1976-11-30
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100 (K761028)Harleco1976-11-30
TEMPERATURE REGULATED FIVE CELL HOLDERS (K760769)The Perkin-Elmer Corp.1976-11-30
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL (K761029)Harleco1976-11-30
REAGENT SYSTEM (NO. SC 135) (K760711)Sigma Chemical Co.1976-11-30
AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL (K761026)Harleco Diagnostics1976-11-30
TRIGLYCERIDES TEST (K760713)Boehringer Mannheim Corp.1976-11-29
SCATTERED TRANSMISSION ACCESSORY (K760737)The Perkin-Elmer Corp.1976-11-24
SIGMA PROCED #SC165 (K760685)Sigma Chemical Co.1976-11-24
LANCER AUTOANALYZER MANIFOLD PUMP TUB (K760622)Sherwood Medical Industries1976-11-24
ACA PHOSPHORUS ANALYTICAL TEST PACK (K760634)E.I. Dupont DE Nemours & Co., Inc.1976-11-24
SERALUTE (K760572)Miles Laboratories, Inc.1976-11-23
MINICON CONCENTRATOR (K760592)Amicon, Inc.1976-11-23
TEST SYSTEM, THYROID STIM. HORMONE ASSAY (K760255)Corning Medical & Scientific1976-11-19
MINIATURE ASCENDING PAPER CHROMATO- (K760908)Ackerman Nuclear, Inc.1976-11-19
ACA DATA MATE ACCESSORY (K760739)E.I. Dupont DE Nemours & Co., Inc.1976-11-16
CORTISOL REAGENT SYSTEM (K760939)Beckman Instruments, Inc.1976-11-16
PH METER-130 (.001 PH) (K760789)Corning Medical & Scientific1976-11-16
INORGANIC PHOSPHOROUS REAGENT (K760990)Worthington Biochemical Corp.1976-11-16
SPINETTE CENTRIFUGE (K761013)Damon Corp.1976-11-16
PH METER-125 (.01 PH) (K760788)Corning Medical & Scientific1976-11-16
GAMMA SCINTILLATION COUNTER (K760900)Beckman Instruments, Inc.1976-11-16
BIOCEPT-G (K760336)Wampole Laboratories1976-11-12
CAT-A-KIT (K760920)The Upjohn Co.1976-11-09
TRIS BICARBONATE DILUENT (K760818)Hyland Therapeutic Div., Travenol Laboratories1976-11-05
ENZYMATIC AMYLASE REAGENT KIT (K760415)Beckman Instruments, Inc.1976-11-05
ENZYMATIC BUN REAGENT KIT (K760414)Beckman Instruments, Inc.1976-11-05
KETOTROL-E (K760885)Sigma Chemical Co.1976-11-05
LIQUID SCINTILLATION COUNTER (K760424)Beckman Instruments, Inc.1976-11-02
LDH SUBSTRATE (K760412)J.T. Baker Chemical Co.1976-11-02
PROCEDURE NO. 710-EP FOR ALK.PHOS. (K760862)Sigma Chemical Co.1976-11-02
POTASSIUM SODIUM TARTRATE (K760408)J.T. Baker Chemical Co.1976-11-02
SODIUM NITRITE (K760409)J.T. Baker Chemical Co.1976-11-02
PRODUCT #K3002 KETOTROL-N(URINE CONTROL) (K760863)Sigma Chemical Co.1976-11-02
LANCER MB/CPK ISOENZYME KIT (K760871)Sherwood Medical Industries1976-11-02
TSH RIA KIT (K760801)Diagnostic Products Corp.1976-11-01
BLASTOMYCES YEAST ANTIGEN (K760828)I M, Inc.1976-11-01
REAGENT, CHLORIDOMETER ACID (K760394)Bulcher Instruments1976-11-01
BUN-REATIVE (K760430)Boehringer Mannheim Corp.1976-11-01
BROMCRESOL GREEN (K760543)Fisher Scientific Co., LLC1976-11-01
REAGENTS FOR BLOOD GAS INSTRUMENTATION (K760748)Alko Scientific Co.1976-11-01
RADIOASSAY KIT, IM.72 FSH (K760373)Amersham Corp.1976-11-01
REAGENT, LACTATE DEHYDROGENASE (K760476)Simmler & Son, Inc.1976-11-01
PRINTER (K760553)Turner Assoc.1976-11-01
COUNTER, RACK GAMMA (#1270) (K760470)Lkb Instruments, Inc.1976-11-01
REAGENT KIT, ENZYMATIC CO2 (K760546)Beckman Instruments, Inc.1976-11-01
REAGENT, Y-GT MAX-PACK (K760366)Calbiochem1976-11-01
REAGENT, AMP BUFFER DIAGNOSTIC (K760397)J.T. Baker Chemical Co.1976-11-01
TEST, REFORMULATED HYCEL HMA CALCIUM (K760468)Hycel, Inc.1976-11-01
PHOTOMETER, SEROMETER (MODEL 380) (K760395)Mallinckrodt Critical Care1976-11-01
REAGENT, TOTAL PROTEIN DETERMINATION (K760480)Simmler & Son, Inc.1976-10-29
REAGENT, ALBUMIN DETERMINATION (K760473)Simmler & Son, Inc.1976-10-29
REAGENT, TOTAL BILIRUBIN DETERMINATION (K760479)Simmler & Son, Inc.1976-10-29
CLINICAL SPECTROPHOTOMETER (K760672)The Dow Chemical Co.1976-10-29
INSTRUMENTED SYSTEM FOR URINALYSIS (K760472)Miles Laboratories, Inc.1976-10-29
NAD (SPOONPAK CONTAINER) (K760411)J.T. Baker Chemical Co.1976-10-29
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY (K760591)Sigma Chemical Co.1976-10-29
REAGENT, BUN (UREA NITROGEN) DETERM. (K760478)Simmler & Son, Inc.1976-10-29
REAGENT, MAGNESIUM CHLORIDE (K760398)J.T. Baker Chemical Co.1976-10-29
ROTATOR, FIXED SPEED (K760467)Lederle Laboratories1976-10-29
REAGENT, ALKALINE PHOSPHATASE DETERM. (K760474)Simmler & Son, Inc.1976-10-29
LIPID CONTROL (K760449)Sigma Chemical Co.1976-10-29
AMP BUFFER (K760410)J.T. Baker Chemical Co.1976-10-29
T-3 UPTAKE KIT (K760802)Diagnostic Products Corp.1976-10-29
REAGENT, CALCIUM DETERMINATION (K760475)Simmler & Son, Inc.1976-10-29
SULFANILIC ACID (K760407)J.T. Baker Chemical Co.1976-10-29
REAGENTS-4 FOR URIC ACID DETERMINATION (K760477)Simmler & Son, Inc.1976-10-29
CAFFEINE DILUENT (K760406)J.T. Baker Chemical Co.1976-10-29
HEMAFLOUR ZP (K760506)Buchler Instruments, Inc.1976-10-28
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (K760346)Princeton Biomedix1976-10-27
REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 (K760348)Sigma Chemical Co.1976-10-27
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