Chromatographic Separation, Cpk Isoenzymes
FDA product code JHT · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
21510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Intl. Immunoassay Laboratories, Inc. 4
- Helena Laboratories 3
- Coulter Electronics, Inc. 2
- Harleco 1
- Boehringer Mannheim Corp. 1
- Hoffmann-La Roche, Inc. 1
- Clinical Sciences, Inc. 1
- Gemini, Inc. 1
- Gelman Sciences, Inc. 1
- Serapine Corp. 1
- Diagnostic Chemicals, Ltd. (Usa) 1
- Data Medical Associates, Inc. 1
- Diagnostic Systems Laboratories, Inc. 1
- Princeton BioMeditech Corp. 1
- Spectral Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | Spectral Diagnostics, Inc. | 09/30/2002SE |
| K991299 | Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional | Princeton BioMeditech Corp. | 05/28/1999SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | Helena Laboratories | 04/12/1993SE |
| K904866 | Coulter Ck-Mb Isoenzyme ReagentJHT · Traditional | Coulter Electronics, Inc. | 12/13/1990SE |
| K904721 | DSL Ck-Mb (DSL #3200)JHT · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 05/15/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | Helena Laboratories | 02/16/1990SE |
| K881168 | Creatine Kinase (CK) Isoenzyme MBJHT · Traditional | Data Medical Associates, Inc. | 11/10/1988SE |
| K874284 | Shot-Gun Isolat Proced/Measurement Ck-Mb in SerumJHT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 01/21/1988SE |
| K872041 | Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional | Coulter Electronics, Inc. | 09/16/1987SE |
| K872598 | Micromi-Ck(Tm)JHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 08/03/1987SE |
| K872592 | Imack-Mb(Tm)JHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 07/31/1987SE |
| K831391 | Shot Gun Kit for Ck-MbJHT · Traditional | Serapine Corp. | 11/04/1983SE |
| K823550 | Ck-Isozyme U.V. Reagent SetJHT · Traditional | Gelman Sciences, Inc. | 01/07/1983SE |
| K822124 | Titan Gel CPK Isoenzyme SystemJHT · Traditional | Helena Laboratories | 11/01/1982SE |
| K821964 | 125I Quick-Mb Test Kit for QuantitationJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 07/22/1982SE |
| K810534 | Gemeni Quick-Mb Separation KitJHT · Traditional | Gemini, Inc. | 03/11/1981SE |
| K791826 | CPK Clini Gel KitJHT · Traditional | Clinical Sciences, Inc. | 10/01/1979SE |
| K790357 | Cpk-CsJHT · Traditional | Hoffmann-La Roche, Inc. | 04/04/1979SE |
| K771497 | Ck-MbJHT · Traditional | Boehringer Mannheim Corp. | 08/22/1977SE |
| K760028 | CPK - IsoenzymesJHT · Traditional | Harleco | 09/15/1976SE |