FDA Product Code
FDA Product Code JHS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | 2016-05-25 | Traditional | PDF ↗ |
| K102706 | CKMB UDR ASSAY | SENTINEL CH. SpA | 2011-08-19 | Traditional | PDF ↗ |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 | Traditional | PDF ↗ |
| K062128 | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | Dade Behring, Inc. | 2006-08-21 | Special | PDF ↗ |
| K990439 | CARESIDE CK | Careside, Inc. | 1999-04-19 | Traditional | PDF ↗ |
| K990434 | CARESIDE CKMB | Careside, Inc. | 1999-04-19 | Traditional | PDF ↗ |
| K981495 | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | Diagnostic Products Corp. | 1998-06-10 | Traditional | PDF ↗ |
| K962126 | ACS CKMB II IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 | Traditional | PDF ↗ |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT | Dade Intl., Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K945083 | ACCESS CK-MB REAGENTS | Bio-Rad Laboratories, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943024 | KINASE ISOENZYME | Dupont Medical Products | 1994-08-02 | Traditional | PDF ↗ |
| K941584 | CREATINE KINASE METHOD | Dupont Medical Products | 1994-07-06 | Traditional | PDF ↗ |
| K903025 | ROCHE ISOMUNE- CK | Roche Diagnostic Systems, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K900806 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1990-03-23 | Traditional | PDF ↗ |
| K883223 | CHECK-MM | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K872029 | UNI-FAST CREATINE KINASE TEST (CK) | Sclavo, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K861387 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) | Eastman Kodak Company | 1986-06-27 | Traditional | PDF ↗ |
| K855188 | CPK (UV) REAGENT KIT | Technostics Intl. | 1986-03-05 | Traditional | PDF ↗ |
| K854708 | DART CK-MB REAGENT SYSTEM | Coulter Electronics, Inc. | 1985-12-30 | Traditional | PDF ↗ |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | Intl. Immunoassay Laboratories, Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K823211 | CK-UV REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K820722 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE | Eastman Kodak Company | 1982-04-01 | Traditional | PDF ↗ |
| K813406 | CPK(CK) IN VITRO DIAG. REAGENT SET | Pointe Scientific, Inc., | 1981-12-22 | Traditional | PDF ↗ |
| K810997 | WORTHINGTON CK (NAC) REAGENT SET | Worthington Diagnostic Systems | 1981-04-23 | Traditional | PDF ↗ |
| K803169 | CARDIOZYME PLUS CK-TOTAL #65046 | Harleco | 1981-01-09 | Traditional | PDF ↗ |
| K802521 | CK-MB(IMMUNOLOGICAL) | Biodynamics Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K801668 | QUICK CEPT | Laboratory Diagnostics Co., Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K800028 | WORTHINGTON FLOZYME* CPK (340NM) | Worthington Diagnostic Systems | 1980-01-21 | Traditional | PDF ↗ |
| K792023 | ESKACHEM, CK-MB REAGENT | Smithkline Diagnostics, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K790917 | SPIN CHEM CK-NAC REAGENT | Smithkline Diagnostics, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K790918 | ESKLAB REAGENT TABLETS | Smithkline Diagnostics, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K790916 | CK-NUC REAGENT | Smithkline Diagnostics, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K790343 | DATA-ZYME CK CALORIMETRIC/UV PROCEDURE | Data Medical Associates, Inc. | 1979-05-01 | Traditional | PDF ↗ |
| K790088 | ACA CREATINE KINASE ISOENZYMES | E.I. Dupont DE Nemours & Co., Inc. | 1979-03-12 | Traditional | PDF ↗ |
| K790015 | SERUM, CREATININE PHOSPHOKINASE | Fisher Scientific Co., LLC | 1979-02-15 | Traditional | PDF ↗ |
| K781690 | L-CYSTEINE HYDROCHLORIDE | Fisher Scientific Co., LLC | 1978-10-27 | Traditional | PDF ↗ |
| K781432 | STAT ULTRA VIOLET LIQUID | Beckman Instruments, Inc. | 1978-10-03 | Traditional | PDF ↗ |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | Gamma Enterprises, Inc. | 1978-05-03 | Traditional | PDF ↗ |
Product code JHS · Class II · Clinical Chemistry. Data: openFDA.