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 |
|---|---|---|---|
| May 23, 1979 | K790768 | WAKO CHOLESTEROL TEST Wako Intl., Inc. | CHH |
| May 23, 1979 | K790760 | REAGENT SYSTEM #350HDL, SIGMA PROCEDURE Sigma Chemical Co. | CHH |
| May 23, 1979 | K790724 | ENZYMATIC DETERMINATION Sigma Chemical Co. | CHH |
| May 7, 1979 | K790556 | CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC Calbiochem-Behring Corp. | CHH |
| Nov 22, 1978 | K781740 | REAGENT, HDL Fisher Scientific Co., LLC | CHH |
| Nov 3, 1978 | K781721 | REAGENT SET, CHOLESTEROL Medical Analysis Systems, Inc. | CHH |
| Jul 28, 1978 | K781013 | ENZYMATIC REAGENT FOR CHOLESTEROL MEAS Coulter Electronics, Inc. | CHH |
| Jun 13, 1978 | K780659 | HDL CHOLESTEROL Macomb Chemical Co. | CHH |
| Jun 6, 1978 | K780783 | AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT J.T. Baker Chemical Co. | CHH |
| May 26, 1978 | K780638 | ACCESSORY HDL CHOLESTEROL REAGENT SET The Dow Chemical Co. | CHH |
| May 19, 1978 | K780635 | REAGENT SET HDL CHOLESTEROL Boehringer Mannheim Corp. | CHH |
| May 19, 1978 | K780523 | ULTRACHEM ENZYMATIC CHOLESTEROL 65025 Harleco | CHH |
| Apr 19, 1978 | K780389 | HDL REAGENT SET FOR LIPOPROTEINS Worthington Biochemical Corp. | CHH |
| Apr 6, 1978 | K780331 | CHOLESTEROL RAPID SLAT KIT HDL Pierce Chemical Co. | CHH |
| Jan 12, 1978 | K772311 | WISP MODEL 710 Waters Assoc., Inc. | CHH |
| Oct 25, 1977 | K771731 | CHOLAR PRODU&T #17010 Hi Chem, Inc. | CHH |
| Oct 19, 1977 | K771820 | ENZYMATIC CHOLESTEROL Macomb Chemical Co. | CHH |
| Sep 15, 1977 | K771586 | CHOLOPAP-HDL Advanced Biomedical Methods, Inc. | CHH |
| Sep 13, 1977 | K771582 | HOLESTEROL DELTA TEST ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CHH |
| Sep 13, 1977 | K771508 | MULTISTAT III CHOLESTEROL TEST Instrumentation Laboratory CO | CHH |
| Jul 21, 1977 | K771067 | CHOLESTEROL KIT Environmental Chemical Specialties | CHH |
| Jul 14, 1977 | K770909 | ENZYMATIC CHOLESTEROL REAGENT SET American Monitor Corp. | CHH |
| Jul 11, 1977 | K770780 | REAGENTS Chemetrics Corp. | CHH |
| Jun 8, 1977 | K770483 | CHOLESTEROL REAGENT Smithkline Diagnostics, Inc. | CHH |
| Jun 2, 1977 | K770998 | CHOLESTEROL REAGENT SET The Dow Chemical Co. | CHH |
| Jun 1, 1977 | K770747 | REAGENT SET, CHOLESTEROL, CAT NO. 4024 American Monitor Corp. | CHH |
| Feb 25, 1977 | K770265 | CHOLESTEROL TEST Sclavo, Inc. | CHH |
| Jan 26, 1977 | K761136 | GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT Beckman Instruments, Inc. | CHH |
| Jan 25, 1977 | K761089 | GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT Beckman Instruments, Inc. | CHH |
| Dec 29, 1976 | K761263 | CHOLESTEROL AUTOMATED REAGENT Worthington Biochemical Corp. | CHH |
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