FDA Product Code
FDA Product Code JHT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | Spectral Diagnostics, Inc. | 2002-09-30 | Traditional | PDF ↗ |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | Princeton BioMeditech Corp. | 1999-05-28 | Traditional | PDF ↗ |
| K930359 | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | Helena Laboratories | 1993-04-12 | Traditional | PDF ↗ |
| K904721 | DSL CK-MB (DSL #3200) | Diagnostic Systems Laboratories, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K904866 | COULTER CK-MB ISOENZYME REAGENT | Coulter Electronics, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | Intl. Immunoassay Laboratories, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896170 | REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 | Helena Laboratories | 1990-02-16 | Traditional | PDF ↗ |
| K881168 | CREATINE KINASE (CK) ISOENZYME MB | Data Medical Associates, Inc. | 1988-11-10 | Traditional | PDF ↗ |
| K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | Diagnostic Chemicals, Ltd. (Usa) | 1988-01-21 | Traditional | PDF ↗ |
| K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM | Coulter Electronics, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K872598 | MICROMI-CK(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-08-03 | Traditional | PDF ↗ |
| K872592 | IMACK-MB(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-07-31 | Traditional | PDF ↗ |
| K831391 | SHOT GUN KIT FOR CK-MB | Serapine Corp. | 1983-11-04 | Traditional | PDF ↗ |
| K823550 | CK-ISOZYME U.V. REAGENT SET | Gelman Sciences, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822124 | TITAN GEL CPK ISOENZYME SYSTEM | Helena Laboratories | 1982-11-01 | Traditional | PDF ↗ |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | Intl. Immunoassay Laboratories, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K810534 | GEMENI QUICK-MB SEPARATION KIT | Gemini, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K791826 | CPK CLINI GEL KIT | Clinical Sciences, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K790357 | CPK-CS | Hoffmann-La Roche, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K771497 | CK-MB | Boehringer Mannheim Corp. | 1977-08-22 | Traditional | PDF ↗ |
| K760028 | CPK - ISOENZYMES | Harleco | 1976-09-15 | Traditional | PDF ↗ |
Product code JHT · Class II · Clinical Chemistry. Data: openFDA.