Panels › Clinical Chemistry › Product code CHH · Class 1
Enzymatic Esterase--Oxidase, Cholesterol
Regulation 862.1175
1510(k)s in 12 months (230 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
Top companies in CHH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 1989 | K895158 | VISION WHOLE BLOOD HDL CHOLESTEROL Abbott Laboratories | CHH |
| Aug 28, 1989 | K893916 | EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 Em Diagnostic Systems, Inc. | CHH |
| Jun 19, 1989 | K893479 | CHOLESTEROL REAGENT SET American Monitor Corp. | CHH |
| Jun 16, 1989 | K891922 | AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 American Research Products Co. | CHH |
| Jun 7, 1989 | K892238 | CLA 200 CHEMPRO(R) LIPID ANALYZER Johnson & Johnson Professionals, Inc. | CHH |
| May 3, 1989 | K890334 | TOTAL CHOLESTEROL REAGENT Alpkem Corp. | CHH |
| Apr 26, 1989 | K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA Photec Diagnostics, Inc. | CHH |
| Apr 26, 1989 | K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD Photec Diagnostics, Inc. | CHH |
| Apr 10, 1989 | K890990 | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE Hichem Diagnostics | CHH |
| Mar 10, 1989 | K884757 | CLINISTAT CHOLESTEROL REAGENT TEST Heraeus Kulzer, Inc. | CHH |
| Feb 17, 1989 | K885023 | CHOLESTEROL TEST ITEM NUMBER: SR1011 Em Diagnostic Systems, Inc. | CHH |
| Dec 16, 1988 | K883543 | HDL-CHOLESTEROL PRECIPITATING REAGENT Medical Analysis Systems, Inc. | CHH |
| Nov 8, 1988 | K880723 | DIMENSION WHOLE BLOOD CHOLESTEROL Technimed, Inc. | CHH |
| Oct 31, 1988 | K883844 | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 Hichem Diagnostics | CHH |
| Jun 10, 1988 | K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD Chem-Elec, Inc. | CHH |
| Apr 28, 1988 | K880237 | CHOLESTEROL Tech-Neal Scientific, Inc. | CHH |
| Mar 1, 1988 | K880311 | WAKO(TM) AUTOKIT CHOLESTEROL Wako Chemicals USA, Inc. | CHH |
| Mar 1, 1988 | K875131 | (SKD) CHOLESTEROL TEST KIT Smithkline Diagnostics, Inc. | CHH |
| Aug 21, 1987 | K872930 | BIOTROL CHOLESTEROL ENZYMATIQUE COLOR Biotrol, USA, Inc. | CHH |
| Jul 16, 1987 | K872575 | HDL CHOLESTEROL REAGENT Sigma Chemical Co. | CHH |
| Jul 16, 1987 | K872295 | CHOLESTEROL REAGENT Sigma Diagnostics, Inc. | CHH |
| May 18, 1987 | K871676 | ENZYMATIC CHOLESTEROL REAGENT SET Michclone Associates, Inc. | CHH |
| Apr 22, 1987 | K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS Electro-Nucleonics Laboratories, Inc. | CHH |
| Apr 13, 1987 | K871260 | CHOLESTEROL DETERMINATION Biochemical Trade, Inc. | CHH |
| Mar 13, 1987 | K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT Intersect Systems, Inc. | CHH |
| Mar 4, 1987 | K870407 | EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 Em Diagnostic Systems, Inc. | CHH |
| Jan 13, 1987 | K863103 | PEG 6,000 J. D. Assoc. | CHH |
| Dec 4, 1986 | K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST U. S. Diagnostics, Inc. | CHH |
| Nov 24, 1986 | K863927 | CHOLESTEROL Tech-Co, Inc. | CHH |
| Sep 29, 1986 | K863252 | CHOLESTEROL PROCEDURE Data Medical Associates, Inc. | CHH |
| Sep 25, 1986 | K863062 | CHOLESTEROL-E (TOTAL) J. D. Assoc. | CHH |
| Sep 11, 1986 | K863064 | CHOLESTEROL-E (FREE) J. D. Assoc. | CHH |
| Sep 9, 1986 | K863063 | CHOLESTEROL-E FAST (TOTAL) J. D. Assoc. | CHH |
| Aug 19, 1986 | K862707 | EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 Em Diagnostic Systems, Inc. | CHH |
| Jul 16, 1986 | K862507 | FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) Sclavo, Inc. | CHH |
| Jun 13, 1986 | K861659 | CHOLESTEROL PROCEDURE Data Medical Associates, Inc. | CHH |
| Jun 11, 1986 | K861700 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. | CHH |
| Apr 11, 1986 | K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) Trace Scientific , Ltd., AU | CHH |
| Jan 28, 1986 | K855028 | TOTAL CHOLESTEROL REAGENT SET Sterling Diagnostics, Inc. | CHH |
| Jan 17, 1986 | K854426 | KODAK EKTACHEM HDL CHOLESTEROL KIT Eastman Kodak Company | CHH |
| Jan 14, 1986 | K855187 | ENZYMATIC CHOLESTROL REAGENT SET Technostics Intl. | CHH |
| Nov 25, 1985 | K854179 | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL Clinical Data, Inc. | CHH |
| Oct 28, 1985 | K853854 | ASTRA SYSTEMS CHOLESTEROL REAGENT Beckman Instruments, Inc. | CHH |
| Oct 4, 1985 | K853871 | QCA ENZYMATIC CHOLESTEROL Bd Becton Dickinson Vacutainer Systems Preanalytic | CHH |
| Jul 23, 1985 | K852863 | CHOLESTEROL METHOD Catachem, Inc. | CHH |
| Jul 9, 1985 | K850390 | CHOLESTEROL TEST SYSTEM Hans J. Brouwers & Assoc. | CHH |
| May 30, 1985 | K852009 | T-CHO REAGENT Alpkem Corp. | CHH |
| Jan 7, 1985 | K844655 | PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE Boehringer Mannheim Corp. | CHH |
| Jan 3, 1985 | K844242 | CHOLESTEROL REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CHH |
| Sep 28, 1984 | K843510 | PDA CHOLESTEROL Abbott Laboratories | CHH |
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