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 |
|---|---|---|---|
| Sep 28, 1984 | K843222 | ENZYMATIC CHOLESTEROL KIT Livonia Diagnostics, Inc. | CHH |
| Sep 14, 1984 | K843327 | SYSTEMATE CHOLESTEROL 67222 Em Diagnostic Systems, Inc. | CHH |
| Aug 17, 1984 | K842160 | CHOLESTEROL ASSSAY KIT Diagnostic Chemicals, Ltd. (Usa) | CHH |
| Aug 15, 1984 | K842320 | TDX REA CHOLESTEROL Abbott Laboratories | CHH |
| Jul 25, 1984 | K842441 | AXIOM STABLE II CHOLESTEROL TEST Axiom, Inc. | CHH |
| May 9, 1984 | K841182 | MULTIPLE CHEM. MODULE FOR ANALYSIS Beckman Instruments, Inc. | CHH |
| May 1, 1984 | K841053 | CHOLESTEROL REAGENT SET ENZYMATIC Medical Specialties, Inc. | CHH |
| Apr 4, 1984 | K840776 | PARAMAX CHOLESTEROL REAGENT American Dade | CHH |
| Mar 30, 1984 | K840368 | DURAZYME CHOLESTEROL American Monitor Corp. | CHH |
| Mar 23, 1984 | K840189 | TOTAL CHOLESTEROL REAGENT SET Preventive Diagnostics Corp. | CHH |
| Oct 14, 1983 | K832780 | FLOW-PAC SHOLESTEROL REAGENT SET American Research Products Co. | CHH |
| Aug 16, 1983 | K832158 | CHOLESTEROL HIGH PERFORMANCE-K Boehringer Mannheim Corp. | CHH |
| Jul 22, 1983 | K831863 | CHOLESTEROL-ENZYMATIC REAGENT SET Stanbio Laboratory | CHH |
| Jul 19, 1983 | K831700 | MULTICHEM ENZYMATIC CHOLESTEROL SYS Simmler, Inc. | CHH |
| Jul 18, 1983 | K831687 | WAKO CHOLESTEROL CII Wako Chemicals USA, Inc. | CHH |
| Apr 18, 1983 | K830761 | WAKO FREE CHOLESTEROL C TEST Wako Chemicals USA, Inc. | CHH |
| Apr 5, 1983 | K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA Emd Chemicals, Inc. | CHH |
| Feb 28, 1983 | K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. | CHH |
| Jan 14, 1983 | K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC Analytical & Research Chemicals, Inc. | CHH |
| Dec 30, 1982 | K823500 | CHOLESTEROL REAGENT Ac Biochemical Laboratories, Inc. | CHH |
| Dec 22, 1982 | K823354 | ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. | CHH |
| Dec 9, 1982 | K823302 | CHOLESTEROL CHOD-PAP TEST Boehringer Mannheim Corp. | CHH |
| Nov 22, 1982 | K823187 | CHOLESTEROL HIGH SENSIT. REAGENT ENZYM Rai, Inc. | CHH |
| Oct 21, 1982 | K822417 | NEW ENZYMATIC SINGLE REAGENT FREE CHOL. Sclavo, Inc. | CHH |
| Sep 14, 1982 | K822418 | ULTRACHEM ENZYMATIC CHOL. OXIDASE Emd Chemicals, Inc. | CHH |
| Jun 1, 1982 | K821441 | ENZYMATIC CHOLESTERAL OXIDASE #650550 Emd Chemicals, Inc. | CHH |
| May 5, 1982 | K821105 | CHOLESTEZYME-V EIKEN Syn-Kit, Inc. | CHH |
| Apr 26, 1982 | K820951 | ENZYMATIC CHOLESTEROL KIT Anco Medical Reagents & Assoc. | CHH |
| Apr 26, 1982 | K820950 | TOTAL CHOLESTEROL REAGENT SET Sterling Biochemical, Inc. | CHH |
| Mar 11, 1982 | K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM American Monitor Corp. | CHH |
| Feb 18, 1982 | K820263 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES Eastman Kodak Company | CHH |
| Nov 10, 1981 | K813039 | ULTRACHEM E-CHOL, ITEM #65025 Harleco | CHH |
| Aug 31, 1981 | K812293 | CENTRICHEM CHOLESTEROL REAGENT & CALIBRA Baker Diagnostics | CHH |
| Aug 12, 1981 | K812100 | SERALYZER Miles Laboratories, Inc. | CHH |
| Aug 12, 1981 | K812091 | FAST CHOLES-CINET Sclavo, Inc. | CHH |
| Jul 10, 1981 | K811760 | CHOLESTEROL DETERMINATION Biorent Diagnostic, Inc. | CHH |
| Mar 31, 1981 | K810673 | ENZYMATIC CHOLESTEROL Pointe Scientific, Inc., | CHH |
| Feb 26, 1981 | K810405 | CHOLESTEROL REAGENT Gilford Diagnostics | CHH |
| Jan 16, 1981 | K803287 | CHOLESTEROL REAGENT ENZYMATIC Rai, Inc. | CHH |
| Jan 9, 1981 | K803254 | LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. Beckman Instruments, Inc. | CHH |
| Dec 10, 1980 | K802743 | AMES SERA-PAK CHOLESTEROL REAGENT KIT Miles Laboratories, Inc. | CHH |
| Jul 28, 1980 | K801285 | YSI MODELS 23C & 23CM HDL & TOTAL CHOLES Yellow Springs Instrument Co., Inc. | CHH |
| Jun 30, 1980 | K801296 | COBAS REAGENT FOR CHOLESTEROL Roche Analytical Instruments, Inc. | CHH |
| Apr 24, 1980 | K800765 | CENTRIFICHEM CHOLESTEROL Union Carbide Corp. | CHH |
| Mar 20, 1980 | K800457 | LIQUID-STAT LIQUID REAGENT Beckman Instruments, Inc. | CHH |
| Feb 21, 1980 | K800199 | LINEAR ENZYMATIC CHOLESTEROL SYSTEM Simmler, Inc. | CHH |
| Jan 11, 1980 | K792509 | ACA HIGH DENSITY LIPOPROTEIN CHOLES. E.I. Dupont DE Nemours & Co., Inc. | CHH |
| Dec 27, 1979 | K792478 | CHEM-STRATE CHOLESTEROL General Diagnostics | CHH |
| Sep 4, 1979 | K791511 | ENZYMATIC REAGENT SET, 4X250 ML. Macomb Chemical Co. | CHH |
| Jun 28, 1979 | K790947 | AUTO ENZYMATIC CHOLESTEROL Macomb Chemical Co. | CHH |
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