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CHH

230 FDA 510(k) clearances · Product code

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RecordFirmDate
VISION WHOLE BLOOD HDL CHOLESTEROL (K895158)Abbott Laboratories1989-10-02
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 (K893916)Em Diagnostic Systems, Inc.1989-08-28
CHOLESTEROL REAGENT SET (K893479)American Monitor Corp.1989-06-19
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 (K891922)American Research Products Co.1989-06-16
CLA 200 CHEMPRO(R) LIPID ANALYZER (K892238)Johnson & Johnson Professionals, Inc.1989-06-07
TOTAL CHOLESTEROL REAGENT (K890334)Alpkem Corp.1989-05-03
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (K890027)Photec Diagnostics, Inc.1989-04-26
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (K890267)Photec Diagnostics, Inc.1989-04-26
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE (K890990)Hichem Diagnostics1989-04-10
CLINISTAT CHOLESTEROL REAGENT TEST (K884757)Heraeus Kulzer, Inc.1989-03-10
CHOLESTEROL TEST ITEM NUMBER: SR1011 (K885023)Em Diagnostic Systems, Inc.1989-02-17
HDL-CHOLESTEROL PRECIPITATING REAGENT (K883543)Medical Analysis Systems, Inc.1988-12-16
DIMENSION WHOLE BLOOD CHOLESTEROL (K880723)Technimed, Inc.1988-11-08
HI CHEM KINETIC CHOLESTEROL REAGENT #88218 (K883844)Hichem Diagnostics1988-10-31
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (K864159)Chem-Elec, Inc.1988-06-10
CHOLESTEROL (K880237)Tech-Neal Scientific, Inc.1988-04-28
WAKO(TM) AUTOKIT CHOLESTEROL (K880311)Wako Chemicals USA, Inc.1988-03-01
(SKD) CHOLESTEROL TEST KIT (K875131)Smithkline Diagnostics, Inc.1988-03-01
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR (K872930)Biotrol, USA, Inc.1987-08-21
CHOLESTEROL REAGENT (K872295)Sigma Diagnostics, Inc.1987-07-16
HDL CHOLESTEROL REAGENT (K872575)Sigma Chemical Co.1987-07-16
ENZYMATIC CHOLESTEROL REAGENT SET (K871676)Michclone Associates, Inc.1987-05-18
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (K870928)Electro-Nucleonics Laboratories, Inc.1987-04-22
CHOLESTEROL DETERMINATION (K871260)Biochemical Trade, Inc.1987-04-13
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT (K870828)Intersect Systems, Inc.1987-03-13
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 (K870407)Em Diagnostic Systems, Inc.1987-03-04
PEG 6,000 (K863103)J. D. Assoc.1987-01-13
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST (K864081)U. S. Diagnostics, Inc.1986-12-04
CHOLESTEROL (K863927)Tech-Co, Inc.1986-11-24
CHOLESTEROL PROCEDURE (K863252)Data Medical Associates, Inc.1986-09-29
CHOLESTEROL-E (TOTAL) (K863062)J. D. Assoc.1986-09-25
CHOLESTEROL-E (FREE) (K863064)J. D. Assoc.1986-09-11
CHOLESTEROL-E FAST (TOTAL) (K863063)J. D. Assoc.1986-09-09
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 (K862707)Em Diagnostic Systems, Inc.1986-08-19
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) (K862507)Sclavo, Inc.1986-07-16
CHOLESTEROL PROCEDURE (K861659)Data Medical Associates, Inc.1986-06-13
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (K861700)E.I. Dupont DE Nemours & Co., Inc.1986-06-11
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) (K860717)Trace Scientific , Ltd.1986-04-11
TOTAL CHOLESTEROL REAGENT SET (K855028)Sterling Diagnostics, Inc.1986-01-28
KODAK EKTACHEM HDL CHOLESTEROL KIT (K854426)Eastman Kodak Company1986-01-17
ENZYMATIC CHOLESTROL REAGENT SET (K855187)Technostics Intl.1986-01-14
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL (K854179)Clinical Data, Inc.1985-11-25
ASTRA SYSTEMS CHOLESTEROL REAGENT (K853854)Beckman Instruments, Inc.1985-10-28
QCA ENZYMATIC CHOLESTEROL (K853871)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-04
CHOLESTEROL METHOD (K852863)Catachem, Inc.1985-07-23
CHOLESTEROL TEST SYSTEM (K850390)Hans J. Brouwers & Assoc.1985-07-09
T-CHO REAGENT (K852009)Alpkem Corp.1985-05-30
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE (K844655)Boehringer Mannheim Corp.1985-01-07
CHOLESTEROL REAGENT FOR DEMAND ANALYZER (K844242)Advanced Biomedical Methods, Inc.1985-01-03
PDA CHOLESTEROL (K843510)Abbott Laboratories1984-09-28
ENZYMATIC CHOLESTEROL KIT (K843222)Livonia Diagnostics, Inc.1984-09-28
SYSTEMATE CHOLESTEROL 67222 (K843327)Em Diagnostic Systems, Inc.1984-09-14
CHOLESTEROL ASSSAY KIT (K842160)Diagnostic Chemicals, Ltd. (Usa)1984-08-17
TDX REA CHOLESTEROL (K842320)Abbott Laboratories1984-08-15
AXIOM STABLE II CHOLESTEROL TEST (K842441)Axiom, Inc.1984-07-25
MULTIPLE CHEM. MODULE FOR ANALYSIS (K841182)Beckman Instruments, Inc.1984-05-09
CHOLESTEROL REAGENT SET ENZYMATIC (K841053)Medical Specialties, Inc.1984-05-01
PARAMAX CHOLESTEROL REAGENT (K840776)American Dade1984-04-04
DURAZYME CHOLESTEROL (K840368)American Monitor Corp.1984-03-30
TOTAL CHOLESTEROL REAGENT SET (K840189)Preventive Diagnostics Corp.1984-03-23
FLOW-PAC SHOLESTEROL REAGENT SET (K832780)American Research Products Co.1983-10-14
CHOLESTEROL HIGH PERFORMANCE-K (K832158)Boehringer Mannheim Corp.1983-08-16
CHOLESTEROL-ENZYMATIC REAGENT SET (K831863)Stanbio Laboratory1983-07-22
MULTICHEM ENZYMATIC CHOLESTEROL SYS (K831700)Simmler, Inc.1983-07-19
WAKO CHOLESTEROL CII (K831687)Wako Chemicals USA, Inc.1983-07-18
WAKO FREE CHOLESTEROL C TEST (K830761)Wako Chemicals USA, Inc.1983-04-18
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA (K830239)Emd Chemicals, Inc.1983-04-05
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE (K830309)Emd Chemicals, Inc.1983-02-28
ENZYMATIC CHOLESTEROL (COLORIMETRIC (K823784)Analytical & Research Chemicals, Inc.1983-01-14
CHOLESTEROL REAGENT (K823500)Ac Biochemical Laboratories, Inc.1982-12-30
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE (K823354)Emd Chemicals, Inc.1982-12-22
CHOLESTEROL CHOD-PAP TEST (K823302)Boehringer Mannheim Corp.1982-12-09
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM (K823187)Rai, Inc.1982-11-22
NEW ENZYMATIC SINGLE REAGENT FREE CHOL. (K822417)Sclavo, Inc.1982-10-21
ULTRACHEM ENZYMATIC CHOL. OXIDASE (K822418)Emd Chemicals, Inc.1982-09-14
ENZYMATIC CHOLESTERAL OXIDASE #650550 (K821441)Emd Chemicals, Inc.1982-06-01
CHOLESTEZYME-V EIKEN (K821105)Syn-Kit, Inc.1982-05-05
ENZYMATIC CHOLESTEROL KIT (K820951)Anco Medical Reagents & Assoc.1982-04-26
TOTAL CHOLESTEROL REAGENT SET (K820950)Sterling Biochemical, Inc.1982-04-26
ENZYMATIC CHOLESTEROL REAGENT SYSTEM (K820473)American Monitor Corp.1982-03-11
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K820263)Eastman Kodak Company1982-02-18
ULTRACHEM E-CHOL, ITEM #65025 (K813039)Harleco1981-11-10
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA (K812293)Baker Diagnostics1981-08-31
SERALYZER (K812100)Miles Laboratories, Inc.1981-08-12
FAST CHOLES-CINET (K812091)Sclavo, Inc.1981-08-12
CHOLESTEROL DETERMINATION (K811760)Biorent Diagnostic, Inc.1981-07-10
ENZYMATIC CHOLESTEROL (K810673)Pointe Scientific, Inc.,1981-03-31
CHOLESTEROL REAGENT (K810405)Gilford Diagnostics1981-02-26
CHOLESTEROL REAGENT ENZYMATIC (K803287)Rai, Inc.1981-01-16
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. (K803254)Beckman Instruments, Inc.1981-01-09
AMES SERA-PAK CHOLESTEROL REAGENT KIT (K802743)Miles Laboratories, Inc.1980-12-10
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES (K801285)Yellow Springs Instrument Co., Inc.1980-07-28
COBAS REAGENT FOR CHOLESTEROL (K801296)Roche Analytical Instruments, Inc.1980-06-30
CENTRIFICHEM CHOLESTEROL (K800765)Union Carbide Corp.1980-04-24
LIQUID-STAT LIQUID REAGENT (K800457)Beckman Instruments, Inc.1980-03-20
LINEAR ENZYMATIC CHOLESTEROL SYSTEM (K800199)Simmler, Inc.1980-02-21
ACA HIGH DENSITY LIPOPROTEIN CHOLES. (K792509)E.I. Dupont DE Nemours & Co., Inc.1980-01-11
CHEM-STRATE CHOLESTEROL (K792478)General Diagnostics1979-12-27
ENZYMATIC REAGENT SET, 4X250 ML. (K791511)Macomb Chemical Co.1979-09-04
AUTO ENZYMATIC CHOLESTEROL (K790947)Macomb Chemical Co.1979-06-28
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