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Clinical Chemistry

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

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RecordFirmDate
CHOLOPAP-HDL (K771586)Advanced Biomedical Methods, Inc.1977-09-15
LIQ. SCINTILLATION SPECTROPHOTOMETEO (K771369)Beckman Instruments, Inc.1977-09-14
MULTISTAT III X-HBDH TEST (K771474)Instrumentation Laboratory CO1977-09-13
MULTISTAT III ALBUMIN TEST (K771475)Instrumentation Laboratory CO1977-09-13
MULTISTAT III, TOTAL BILIRUBIN TEST (K771621)Instrumentation Laboratory CO1977-09-13
IN VITRO FOLATE RADIOASSAY KIT (K771597)Clinical Assays, Inc.1977-09-13
HOLESTEROL DELTA TEST ASSAY (K771582)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-09-13
MULTISTAT III URIC ACID TEST (K771509)Instrumentation Laboratory CO1977-09-13
MULTISTAT III CHOLESTEROL TEST (K771508)Instrumentation Laboratory CO1977-09-13
MULTISTAT III, AMYLASE TEST (K771622)Instrumentation Laboratory CO1977-09-13
MULTISTAT III CALCIUM TEST (K771468)Instrumentation Laboratory CO1977-09-12
MULTISTAT III PHOSPHOROUS TEST (K771477)Instrumentation Laboratory CO1977-09-12
PREGNANCY TEST KIT (K771514)Generic Laboratory, Ltd.1977-09-12
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI (K771004)Miles Laboratories, Inc.1977-09-12
MULTISTAT III GLUCOSE TEST (K771471)Instrumentation Laboratory CO1977-09-12
MULTISTAT III TOTAL PROTEIN TEST (K771476)Instrumentation Laboratory CO1977-09-12
MULTISTAT III MAGNESIUM TEST (K771469)Instrumentation Laboratory CO1977-09-12
MULTISTAT III ALKALINE PHOSPHATASE (K771470)Instrumentation Laboratory CO1977-09-12
MULTISTAT III GLUCOSE TEST (K771464)Instrumentation Laboratory CO1977-09-02
THYRODOT-4, THYRODOT-SH (K771377)Medcom Diagnostics, Inc.1977-09-02
MULTISTAT III TRIGLYCERIDE TEST (K771472)Instrumentation Laboratory CO1977-09-02
SPECI-MIX (K771617)Thermolyne Corp.1977-09-02
MULTISTAT III ALANINE AMINOTRANSFERASE (K771466)Instrumentation Laboratory CO1977-09-02
SERONORM (K771436)Nyegaard & Co. A/S1977-09-02
AMYLASE ULTRAZYME PLUS (K771388)Harleco1977-09-02
AUTONORM (K771438)Nyegaard & Co. A/S1977-09-02
HYPRONOSTICON TM (K770603)Organon, Inc.1977-09-02
SERONORM LIPID (K771437)Nyegaard & Co. A/S1977-09-02
CK-1 ULTRAZYME PLUS (K771389)Harleco1977-09-02
TRIGLYCERIDE REAGENT SET (K770993)Macomb Chemical Co.1977-09-02
PATHONORM H & L (K771439)Nyegaard & Co. A/S1977-09-02
MULTISTAT III LACTIC DEHYDROGENASE (K771465)Instrumentation Laboratory CO1977-09-02
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID (K771324)Corning Medical & Scientific1977-09-02
SMA II (K771336)Technicon Instruments Corp.1977-08-26
HEMOX-ANALYZER (K771253)3M Company1977-08-25
125 I ALDOSTERONE RIA KIT (K771526)Diagnostic Products Corp.1977-08-25
MULTISTAT III UREA NITROGEN TEST (K771442)Instrumentation Laboratory CO1977-08-22
MULTISTAT III CREATININE TEST (K771443)Instrumentation Laboratory CO1977-08-22
DUAL LAB-LITE LIGHT BOX (K771486)Technilab1977-08-22
MULTISTAT III CPK TEST (K771441)Instrumentation Laboratory CO1977-08-22
KEM-O-MAT (K771513)Coulter Electronics, Inc.1977-08-22
AUTOZYME IMMOBILIZED ENZYME COIL (K771384)Technicon Instruments Corp.1977-08-22
CK-MB (K771497)Boehringer Mannheim Corp.1977-08-22
RTERIAL BLOOD SAMPLING KIT (K771489)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-08-22
FURNACE AUTOSAMPLER, MODEL 155 (K770994)Instrumentation Laboratory CO1977-08-22
ALBUMIN TEST, HMA ALBUMIN TEST (K771259)Hycel, Inc.1977-08-22
QUALICHECK TM (K771444)The London Co.1977-08-16
CREATININE ANALYSIS PRODUCTS (K771365)Abbott Laboratories1977-08-16
LDH-INT TEST (K771343)Hycel, Inc.1977-08-10
TRANSPORTEO MODULE (K771446)Hyland Therapeutic Div., Travenol Laboratories1977-08-10
ELECTROPHORESIS OVEN THERMOMETER (K771323)Corning Medical & Scientific1977-08-10
SPINSEP-TBG (K771341)Nuclear Diagnostics, Inc.1977-08-10
BICHROMATIC ANALYZER ABA-200 (K771345)Abbott Laboratories1977-08-04
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR (K771033)Mid Tech, Inc.1977-08-04
CARDIOZYME CK CONTROL NORMAL (K770973)Dade, Baxter Travenol Diagnostics, Inc.1977-08-04
AUTO-LOGIC II SYSTEM (K771129)Abbott Laboratories1977-08-04
DYNAZYME II ALKALINE PHOSPHATASE (K771085)J.T. Baker Chemical Co.1977-08-04
CARDIOZYME CK-CONTROL ABNORMAL (K770971)Dade, Baxter Travenol Diagnostics, Inc.1977-08-04
T4 RIA TEST SYSTEM (K771221)Monobind1977-08-04
T3 RIA TEST SYSTEM (K771220)Monobind1977-08-04
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. (K771305)Organon, Inc.1977-08-04
LIQUAEMIB SODIUM PRESERVATIVE, ETC. (K771304)Organon, Inc.1977-08-04
TSH RIA TEST SYSTEM (K771222)Monobind1977-08-04
AP ISOTROL, #A 0140 (K771225)Sigma Chemical Co.1977-08-03
ICROTAINEO BRAND TUBE (K771370)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-08-03
GLUCOSE REAGENT (O-TOLUIDINE) (K771314)Mallinckrodt Critical Care1977-08-03
RIA FOR TOTAL THYROXINE (K771309)Abbott Laboratories1977-08-03
HTSH RIA HUMAN THYROID HORMONE RIA (K771235)Abbott Laboratories1977-08-03
CALCIUM REAGENT (K771310)Mallinckrodt Critical Care1977-08-03
CREATININE ANALYZER 2 (K771335)Beckman Instruments, Inc.1977-08-03
BLOOD UREA NITROGEN (BUN) REAGENT (K771312)Mallinckrodt Critical Care1977-08-03
GAMMA GOUNTING SYS., AUTO, MODEL 1400 (K771180)G.D. Searle and Co.1977-08-03
TRIOBEAD-125 DIAGNOSTIC KIT (K771236)Abbott Laboratories1977-08-03
CHOLESTEROL REAGENT (K771313)Mallinckrodt Critical Care1977-08-03
GLUCOSE REAGENT (HEXOHINASE) (K771311)Mallinckrodt Critical Care1977-08-03
SERUM GLUTAMIC PYRUVIC TRANSAMINASE (K770991)Macomb Chemical Co.1977-08-02
WHOLE BLOOD GAS CONTROL (K770950)Dade, Baxter Travenol Diagnostics, Inc.1977-08-02
MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV (K771156)The Perkin-Elmer Corp.1977-08-02
CHOLESTEROL KIT (K771067)Environmental Chemical Specialties1977-07-21
UNIPAK URIC ACID (K771088)Harleco1977-07-21
UNIPAK CHOLESTEROL (K771093)Harleco1977-07-21
CLINICARD UV AMYLASE CHEMISTRY (K771131)Harleco1977-07-21
DIAG. OZYRATE GLUCOSE REAG. SET (K771059)J.T. Baker Chemical Co.1977-07-21
UNIPAK BUN (K771087)Harleco1977-07-21
UNIPAK GLUCOSE (K771091)Harleco1977-07-21
DATA REDUCTION SYSTEM, DP-3000 (K770877)Beckman Instruments, Inc.1977-07-21
UNIPAK TOTAL & DIRECT BILIRUBIN (K771092)Harleco1977-07-21
DIAG. CONDUCTA RATE BUN REAG. SET (K771060)J.T. Baker Chemical Co.1977-07-21
CENTRIFICHEM TRIGLYCERIDE CALI. STD. (K771215)Union Carbide Corp.1977-07-21
UNIPAK ALBUMIN (K771094)Harleco1977-07-21
UNIPAK TOTAL BILIRUBIN (K771089)Harleco1977-07-21
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET (K771216)Union Carbide Corp.1977-07-21
TMA BICARBONATE DILUENT (K771044)Hyland Therapeutic Div., Travenol Laboratories1977-07-15
LIPOPROTEIN PROFILING SYSTEM (K770948)Beckman Instruments, Inc.1977-07-15
TRENDAR (K771000)Hi Chem, Inc.1977-07-15
T3 CLASP RIA KIT (K771142)E. R. Squibb & Sons, Inc.1977-07-14
AUTO TOTAL PROTEIN FOR ANALYZER (K770887)Harleco1977-07-14
TRIGLYCERIDE ENZYMATIC METHOD (K770841)Union Carbide Corp.1977-07-14
ENZYMATIC CHOLESTEROL REAGENT SET (K770909)American Monitor Corp.1977-07-14
ULTRAZYME PLUS HBD (K770871)Harleco1977-07-14
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