FDA Product Code
FDA Product Code CHH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1175
510(k) Clearances — 230 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K790760 | REAGENT SYSTEM #350HDL, SIGMA PROCEDURE | Sigma Chemical Co. | 1979-05-23 | Traditional | PDF ↗ |
| K790768 | WAKO CHOLESTEROL TEST | Wako Intl., Inc. | 1979-05-23 | Traditional | PDF ↗ |
| K790724 | ENZYMATIC DETERMINATION | Sigma Chemical Co. | 1979-05-23 | Traditional | PDF ↗ |
| K790556 | CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC | Calbiochem-Behring Corp. | 1979-05-07 | Traditional | PDF ↗ |
| K781740 | REAGENT, HDL | Fisher Scientific Co., LLC | 1978-11-22 | Traditional | PDF ↗ |
| K781721 | REAGENT SET, CHOLESTEROL | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781013 | ENZYMATIC REAGENT FOR CHOLESTEROL MEAS | Coulter Electronics, Inc. | 1978-07-28 | Traditional | PDF ↗ |
| K780659 | HDL CHOLESTEROL | Macomb Chemical Co. | 1978-06-13 | Traditional | PDF ↗ |
| K780783 | AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT | J.T. Baker Chemical Co. | 1978-06-06 | Traditional | PDF ↗ |
| K780638 | ACCESSORY HDL CHOLESTEROL REAGENT SET | The Dow Chemical Co. | 1978-05-26 | Traditional | PDF ↗ |
| K780635 | REAGENT SET HDL CHOLESTEROL | Boehringer Mannheim Corp. | 1978-05-19 | Traditional | PDF ↗ |
| K780523 | ULTRACHEM ENZYMATIC CHOLESTEROL 65025 | Harleco | 1978-05-19 | Traditional | PDF ↗ |
| K780389 | HDL REAGENT SET FOR LIPOPROTEINS | Worthington Biochemical Corp. | 1978-04-19 | Traditional | PDF ↗ |
| K780331 | CHOLESTEROL RAPID SLAT KIT HDL | Pierce Chemical Co. | 1978-04-06 | Traditional | PDF ↗ |
| K772311 | WISP MODEL 710 | Waters Assoc., Inc. | 1978-01-12 | Traditional | PDF ↗ |
| K771731 | CHOLAR PRODU&T #17010 | Hi Chem, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771820 | ENZYMATIC CHOLESTEROL | Macomb Chemical Co. | 1977-10-19 | Traditional | PDF ↗ |
| K771586 | CHOLOPAP-HDL | Advanced Biomedical Methods, Inc. | 1977-09-15 | Traditional | PDF ↗ |
| K771582 | HOLESTEROL DELTA TEST ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-13 | Traditional | PDF ↗ |
| K771508 | MULTISTAT III CHOLESTEROL TEST | Instrumentation Laboratory CO | 1977-09-13 | Traditional | PDF ↗ |
| K771067 | CHOLESTEROL KIT | Environmental Chemical Specialties | 1977-07-21 | Traditional | PDF ↗ |
| K770909 | ENZYMATIC CHOLESTEROL REAGENT SET | American Monitor Corp. | 1977-07-14 | Traditional | PDF ↗ |
| K770780 | REAGENTS | Chemetrics Corp. | 1977-07-11 | Traditional | PDF ↗ |
| K770483 | CHOLESTEROL REAGENT | Smithkline Diagnostics, Inc. | 1977-06-08 | Traditional | PDF ↗ |
| K770998 | CHOLESTEROL REAGENT SET | The Dow Chemical Co. | 1977-06-02 | Traditional | PDF ↗ |
| K770747 | REAGENT SET, CHOLESTEROL, CAT NO. 4024 | American Monitor Corp. | 1977-06-01 | Traditional | PDF ↗ |
| K770265 | CHOLESTEROL TEST | Sclavo, Inc. | 1977-02-25 | Traditional | PDF ↗ |
| K761136 | GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT | Beckman Instruments, Inc. | 1977-01-26 | Traditional | PDF ↗ |
| K761089 | GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT | Beckman Instruments, Inc. | 1977-01-25 | Traditional | PDF ↗ |
| K761263 | CHOLESTEROL AUTOMATED REAGENT | Worthington Biochemical Corp. | 1976-12-29 | Traditional | PDF ↗ |
Product code CHH · Class I · Clinical Chemistry. Data: openFDA.