FDA Product Code
FDA Product Code CGS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 123 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K820644 | RAICHEM TM CREATINE KINASE REAGENT | Reagents Applications, Inc. | 1982-04-01 | Traditional | PDF ↗ |
| K812593 | ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 | Harleco | 1981-10-02 | Traditional | PDF ↗ |
| K811574 | CARDIOZYME PLUS CK-TOTAL ITEM #65046 | Harleco | 1981-06-25 | Traditional | PDF ↗ |
| K811576 | CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) | Harleco | 1981-06-25 | Traditional | PDF ↗ |
| K810853 | CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT | The Upjohn Co. | 1981-05-29 | Traditional | PDF ↗ |
| K803301 | CREATINE KINASE REAGENT | Gilford Diagnostics | 1981-01-16 | Traditional | PDF ↗ |
| K801299 | COBAS CK-NAC REAGENT | Roche Analytical Instruments, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K800127 | CENTRIFICHEM CK | Union Carbide Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K792477 | CHEM-STRATE CK-NAC | General Diagnostics | 1979-12-27 | Traditional | PDF ↗ |
| K781859 | REAGENT SYSTEM, NO 46-OV FOR CPK | Sigma Chemical Co. | 1978-12-04 | Traditional | PDF ↗ |
| K781719 | CPK REAGENT SET, NAD REDUCTION | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781149 | CPK-L TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 | Traditional | PDF ↗ |
| K780311 | DIAGNOSTIC KIT, CPK | Sclavo, Inc. | 1978-04-05 | Traditional | PDF ↗ |
| K780100 | ULTRAZYME PLUS CK-1 | Harleco | 1978-03-09 | Traditional | PDF ↗ |
| K780070 | CPK REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K772352 | STAC SYSTEM - ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1978-01-31 | Traditional | PDF ↗ |
| K772258 | CLINICARD CK-II | Harleco | 1978-01-05 | Traditional | PDF ↗ |
| K771849 | CPK COLOR TEST KIT | Mallinckrodt Critical Care | 1977-11-03 | Traditional | PDF ↗ |
| K771389 | CK-1 ULTRAZYME PLUS | Harleco | 1977-09-02 | Traditional | PDF ↗ |
| K771441 | MULTISTAT III CPK TEST | Instrumentation Laboratory CO | 1977-08-22 | Traditional | PDF ↗ |
| K770694 | CPK ULTRAZYME PLUS | Harleco Diagnostics | 1977-07-01 | Traditional | PDF ↗ |
| K770319 | REAGENT CPK, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K761344 | DYNAZYME-II TM CK-230 KIT | J.T. Baker Chemical Co. | 1977-01-05 | Traditional | PDF ↗ |
Product code CGS · Class II · Clinical Chemistry. Data: openFDA.