JHT — Chromatographic Separation, Cpk Isoenzymes Class II
FDA Device Classification
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 |