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Clinical Chemistry

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

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RecordFirmDate
ULTRAZYME PLUS GPT (K770882)Harleco1977-07-14
QUANTIMUNE NEONATAL & THYROXINE RIA (K771135)Bio-Rad1977-07-14
FLUCOSE U.V. TEST KIT (K770844)Mallinckrodt Critical Care1977-07-14
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER (K770886)Harleco1977-07-14
COLORIMETRIC DETERM. SOCITRATE DEHYDRO. (K770902)Sigma Chemical Co.1977-07-14
ULTRAZYME PLUS ALP (K770870)Harleco1977-07-14
TRIGLYCERIDE KIT (K771068)Environmental Chemical Specialties1977-07-12
SHAVE PREP SET (K770795)Lukens Corp.1977-07-11
ULTRACHEM CALCIUM (K770817)Harleco1977-07-11
INORGANIC PHOSPHORUS STANDARDS (K771143)Worthington Biochemical Corp.1977-07-11
STATZYME URIC ACID REAGENT (K770831)Worthington Biochemical Corp.1977-07-11
CENTRIA SEPARATION COLUMNS TYPE A (K771118)Clinical Diagnostics, Inc.1977-07-11
ULTRACHEM ALBUMIN (K770816)Harleco1977-07-11
PIPETTE, DISPENSING, MODEL ADP-30SD (K770772)G.D. Searle and Co.1977-07-11
ULTRACHEM CREATININE (K770819)Harleco1977-07-11
STATZYME GLUCOSE (K771001)Worthington Biochemical Corp.1977-07-11
ULTRAZYME PLUS, LDH (K770818)Harleco1977-07-11
PIPETTE, DILUTING, MODEL ADP-30SD (K770773)G.D. Searle and Co.1977-07-11
A-GENT ALBUMIN (K770822)Abbott Laboratories1977-07-11
ULTRACHEM INORGANIC PHOSPHORUS (K770820)Harleco1977-07-11
REAGENTS (K770780)Chemetrics Corp.1977-07-11
LYTETEK SYSTEM (K770774)Boehringer Mannheim Corp.1977-07-11
PLATELET AGITATOR (K770830)Helmer Labs, Inc.1977-07-11
LABORATORY EXPENDABLE PRODUCTS (K770594)Abco Dealers, Inc.1977-07-06
IN VITRO DIAG. FOR URIC ACID (K770767)Smithkline Diagnostics, Inc.1977-07-05
REAGENT KIT, ENZYMATIC AMYLASE (K770750)Beckman Instruments, Inc.1977-07-05
CPK ULTRAZYME PLUS (K770694)Harleco Diagnostics1977-07-01
BLOOD COLLECTION TUBE, GRAY (K771053)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, RED (K771055)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, GREEN (K771056)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, BLUE (K771054)Sherwood Medical Industries1977-06-29
REAGENT SYSTEM (K770504)American Monitor Corp.1977-06-27
BLOOD COLLECTION TUBE, LAVENDER (K771052)Sherwood Medical Industries1977-06-27
AQUEOUS PH/BLOOD GAS CONTROLS (K770228)Instrumentation Laboratory CO1977-06-27
CALCULATOR, ENZYME, TURNER (K770671)Turner Assoc.1977-06-27
PHADEBAS T3 U TEST (K771078)Pharmacia, Inc.1977-06-27
QUANTA-MATE VITAMIN B-12/FOLATE RA (K771047)Bio-Rad1977-06-27
DETECTOR, IR, MODEL GC-33 (K770639)Peokin-Elmer Corp.1977-06-24
UN, UV DELTA TEST ASSAY (K770654)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-24
REAGENT SYSTEM, THYROXINE, ARIA (K770733)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-24
CREATININE TEST, SUPER SEVENTEEN (K770643)Hycel, Inc.1977-06-24
DETECTOR, UV, MOLEL GC-55 (K770638)Peokin-Elmer Corp.1977-06-24
REAGENT SET, RENORPACE (K770765)G.D. Searle and Co.1977-06-24
SPECTROPHOTOMETER, MODEL 751 (K770645)Instrumentation Laboratory CO1977-06-24
MERCURY/HYDRIDE SYSTEM MHS-1 (K770637)The Perkin-Elmer Corp.1977-06-23
CENTRIA CORTISOL RIA (K771117)Clinical Diagnostics, Inc.1977-06-23
SERUM SET, THYROID CONTROL (K770739)G.D. Searle and Co.1977-06-22
REAGENT SET, T-4, CPB (K770737)G.D. Searle and Co.1977-06-22
REAGENT SYSTEM, PROGESTERONE, ARIA (K770732)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-22
RADIOASSAY TUBES & RADIOASSAY TUBE CAPS (K770740)G.D. Searle and Co.1977-06-22
REAGENT, T-3 UPTAKE (K770738)G.D. Searle and Co.1977-06-22
TOTAL THYROXINE (RIA) REAGENT SET (K770940)The Dow Chemical Co.1977-06-22
DETER. OF PHOSPHOHEXOSE ISOMERASE (K770577)Sigma Chemical Co.1977-06-17
LIQUI SOL T4 RIA TEST KIT (K770918)Damon Corp.1977-06-17
LDH ULTRAZYME PLUS (K770613)Harleco Diagnostics1977-06-17
REAGENT, CHLORIDE, COULTER (K770752)Coulter Electronics, Inc.1977-06-17
CLASP RIA KIT, HTSH (K770915)E. R. Squibb & Sons, Inc.1977-06-14
QUANTIMUNE T-3 RIA (K770648)Bio-Rad1977-06-14
ANALYZER, SODIUM/POTASSIUM NOVA L (K770601)Nova Biomedical Corp.1977-06-14
TSH RADIOIMMUNOASSAY (K770892)Kallestad Laboratories, Inc.1977-06-14
CHOLESTEROL REAGENT (K770483)Smithkline Diagnostics, Inc.1977-06-08
CALCIUM/MAGNESIUM ANALYZER (K770570)Beckman Instruments, Inc.1977-06-08
REAGENT SYSTEM 153-UV (K770519)Sigma Chemical Co.1977-06-03
CPK ISOENZYME CONTROL (K770555)Bio-Reagents & Diagnostics, Inc.1977-06-03
URIC ACID TEST KIT (K770564)Mallinckrodt Critical Care1977-06-03
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 (K770520)Kallestad Laboratories, Inc.1977-06-03
CENTRIFI CHEM CALCIUM REAGENT (K770460)Union Carbide Corp.1977-06-02
RIA-120 AND ESTRIOL REAGENT SYSTEM (K770465)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-02
CHOLESTEROL REAGENT SET (K770998)The Dow Chemical Co.1977-06-02
TECHNICON SMA & AAII SYSTEMS (K770406)Boehringer Laboratories1977-06-02
WORTHINGTON BUN (K770470)Worthington Biochemical Corp.1977-06-02
MONITOR, PATIENT, MODEL PM-20N (K770736)Cavitron Corp.1977-06-02
TEST, FERROZINE IRON & IRON BINDING (K770748)Hycel, Inc.1977-06-01
REAGENT SET, CHOLESTEROL, CAT NO. 4024 (K770747)American Monitor Corp.1977-06-01
LUTEINIZING HORMONE RIA REAGENT, LH-RIA (K770854)Nichols Institute Diagnostics1977-05-26
T3 UPTAKE REAGENT SET (K770845)The Dow Chemical Co.1977-05-26
T-3 RIA REAGENT SET (K770677)G.D. Searle and Co.1977-05-20
T-4 RIA REAGENT SET (K770676)G.D. Searle and Co.1977-05-20
RIALYZE HPL (RIA) (K770659)Miles Laboratories, Inc.1977-05-20
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (K770458)Icn Pharmaceuticals, Inc.1977-05-10
IN VITRO DIAGNOSTIC REAGENTS (K770506)Norwood Scientific Associates, Inc.1977-05-06
GLUCOSE PROCEDURE, TEKPOINT DIRECT (K770455)Icn Pharmaceuticals, Inc.1977-05-03
URINALYSIS PROFICIENCY (K770390)Miles Laboratories, Inc.1977-05-03
CHEMISTRY, COULTER (K770679)Coulter Electronics, Inc.1977-05-03
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (K770457)Icn Pharmaceuticals, Inc.1977-05-03
PROTEIN PROCEDURE, TEKPOINT TOTAL (K770452)Icn Pharmaceuticals, Inc.1977-05-03
CHLORIDE PROCEDURE, TEKPOINT DIRECT (K770450)Icn Pharmaceuticals, Inc.1977-05-03
CALCIUM PROCEDURE, TEKPOINT DIRECT (K770449)Icn Pharmaceuticals, Inc.1977-05-03
CREATININE PROCEDURE, TEKPOINT (K770454)Icn Pharmaceuticals, Inc.1977-05-03
ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL (K770451)Icn Pharmaceuticals, Inc.1977-05-03
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT (K770456)Icn Pharmaceuticals, Inc.1977-05-03
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (K770453)Icn Pharmaceuticals, Inc.1977-05-03
URIC ACID PROCEDURE, TEKPOINT DIRECT (K770459)Icn Pharmaceuticals, Inc.1977-04-29
THYROSCREEN TM T4 DIAGNOSTIC KIT (K770474)Abbott Laboratories1977-04-28
RIA KIT, T4 CLASP (K770726)Squibb & Sons, Inc.1977-04-28
PROPANE, HIGH PURITY, INSTRUMENT GRADE (K770393)Hycel, Inc.1977-04-26
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (K770401)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-04-26
REAGENT, AMYLASE LIPASE (K770400)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-04-26
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A (K770010)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B (K770011)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
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