FDA Product Code
FDA Product Code JHW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162526 | Creatine Kinase-MB | Roche Diagnostics | 2017-05-26 | Traditional | PDF ↗ |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Elitechgroup | 2014-07-18 | Traditional | PDF ↗ |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Elitechgroup | 2012-08-22 | Traditional | PDF ↗ |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | Wiener Laboratories Saic | 2003-01-03 | Traditional | PDF ↗ |
| K003158 | ROCHE DIAGNOSTICS CK-MB | Roche Diagnostics Corp. | 2000-12-18 | Traditional | PDF ↗ |
| K961501 | ELECSYS CK-MB | Boehringer Mannheim Corp. | 1996-06-11 | Traditional | PDF ↗ |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K944325 | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN | Princeton BioMeditech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Biochemical Trade, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K935924 | AXSYM CK-MB | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K931050 | CARDIO REP CK ISOENZYME KIT - 3310 | Helena Laboratories | 1993-04-20 | Traditional | PDF ↗ |
| K913349 | STAMBI-CK | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 | Traditional | PDF ↗ |
| K905588 | CREATINE KINASE UV REAGENT SET | Biochemical Trade, Inc. | 1991-01-17 | Traditional | PDF ↗ |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Intl. Immunoassay Laboratories, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K883222 | ISOFOR-MM (TM) | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K881801 | IMPRES-MB | Intl. Immunoassay Laboratories, Inc. | 1988-06-08 | Traditional | PDF ↗ |
| K822897 | DSL 1700 | Diagnostic Systems Laboratories, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K811573 | CARDIOZYME PLUS CK-MB ITEM #65045 | Harleco | 1981-06-25 | Traditional | PDF ↗ |
| K811575 | CARDIOZYME PLUS CK-MB ITEM #65045 (G) | Harleco | 1981-06-25 | Traditional | PDF ↗ |
| K810905 | ISOMUNE-CK | Hoffmann-La Roche, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | The Dow Chemical Co. | 1981-04-14 | Traditional | PDF ↗ |
| K803168 | CARDIO ZYME PLUS CK-MB #65045 | Harleco | 1981-01-09 | Traditional | PDF ↗ |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Macomb Chemical Co. | 1980-01-11 | Traditional | PDF ↗ |
| K782015 | A-GENT CK-MB | Abbott Laboratories | 1979-02-01 | Traditional | PDF ↗ |
| K781124 | CPK ISOENZYME REAGENT | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K772172 | DYNAZYME TM II CARDIAK-MB | J.T. Baker Chemical Co. | 1977-12-06 | Traditional | PDF ↗ |
Product code JHW · Class II · Clinical Chemistry. Data: openFDA.