JHT — Chromatographic Separation, Cpk Isoenzymes Class II
FDA product code JHT covers "Chromatographic Separation, Cpk Isoenzymes", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JHT
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022409 | spectral diagnostics | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | September 30, 2002 |
| K991299 | princeton biomeditech | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI | May 28, 1999 |
| K930359 | helena laboratories | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | April 12, 1993 |
| K904866 | coulter electronics | COULTER CK-MB ISOENZYME REAGENT | December 13, 1990 |
| K904721 | diagnostic systems laboratories | DSL CK-MB (DSL #3200) | December 13, 1990 |
| K901450 | intl. immunoassay laboratories | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | May 15, 1990 |
| K896170 | helena laboratories | REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 | February 16, 1990 |
| K881168 | data medical associates | CREATINE KINASE (CK) ISOENZYME MB | November 10, 1988 |
| K874284 | diagnostic chemicals, ltd. (usa) | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | January 21, 1988 |
| K872041 | coulter electronics | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM | September 16, 1987 |
| K872598 | intl. immunoassay laboratories | MICROMI-CK(TM) | August 3, 1987 |
| K872592 | intl. immunoassay laboratories | IMACK-MB(TM) | July 31, 1987 |
| K831391 | serapine | SHOT GUN KIT FOR CK-MB | November 4, 1983 |
| K823550 | gelman sciences | CK-ISOZYME U.V. REAGENT SET | January 7, 1983 |
| K822124 | helena laboratories | TITAN GEL CPK ISOENZYME SYSTEM | November 1, 1982 |
| K821964 | intl. immunoassay laboratories | 125I QUICK-MB TEST KIT FOR QUANTITATION | July 22, 1982 |
| K810534 | gemini | GEMENI QUICK-MB SEPARATION KIT | March 11, 1981 |
| K791826 | clinical sciences | CPK CLINI GEL KIT | October 1, 1979 |
| K790357 | hoffmann-la roche | CPK-CS | April 4, 1979 |
| K771497 | boehringer mannheim | CK-MB | August 22, 1977 |