U.V. Method, Cpk Isoenzymes
FDA product code JHW · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
27510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Intl. Immunoassay Laboratories, Inc. 5
- Harleco 3
- Elitechgroup 2
- Roche Diagnostics Corp. 2
- Biochemical Trade, Inc. 2
- Abbott Laboratories 2
- The Dow Chemical Co. 1
- Hoffmann-La Roche, Inc. 1
- Diagnostic Systems Laboratories, Inc. 1
- Macomb Chemical Co. 1
- Helena Laboratories 1
- Princeton BioMeditech Corp. 1
- Miles, Inc. 1
- Boehringer Mannheim Corp. 1
- Electrophoresis Corp. of America 1
- Wiener Laboratories Saic 1
- J.T. Baker Chemical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162526 | Creatine Kinase-MBJHW · Traditional | Roche Diagnostics | 05/26/2017SE |
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | Elitechgroup | 07/18/2014SE |
| K122083 | Elitech Clinical Systems CK Nac SLJHW · Traditional | Elitechgroup | 08/22/2012SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | Wiener Laboratories Saic | 01/03/2003SE |
| K003158 | Roche Diagnostics Ck-MbJHW · Traditional | Roche Diagnostics Corp. | 12/18/2000SE |
| K961501 | Elecsys Ck-MbJHW · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | Miles, Inc. | 03/13/1995SE |
| K944325 | Lifesign, Care Point, Vitalsign, AccusignJHW · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | Biochemical Trade, Inc. | 11/21/1994SE |
| K935924 | Axsym Ck-MbJHW · Traditional | Abbott Laboratories | 06/21/1994SE |
| K931050 | Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional | Helena Laboratories | 04/20/1993SE |
| K913349 | Stambi-CkJHW · Traditional | Intl. Immunoassay Laboratories, Inc. | 10/23/1991SE |
| K912231 | Proposed New Use of Instrument System and Test KitJHW · Traditional | Intl. Immunoassay Laboratories, Inc. | 07/08/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | Biochemical Trade, Inc. | 01/17/1991SE |
| K903508 | Labelling Changes to Impres-Mb-XJHW · Traditional | Intl. Immunoassay Laboratories, Inc. | 09/07/1990SE |
| K883222 | Isofor-Mm (TM)JHW · Traditional | Intl. Immunoassay Laboratories, Inc. | 09/30/1988SE |
| K881801 | Impres-MbJHW · Traditional | Intl. Immunoassay Laboratories, Inc. | 06/08/1988SE |
| K822897 | DSL 1700JHW · Traditional | Diagnostic Systems Laboratories, Inc. | 12/15/1982SE |
| K811575 | Cardiozyme Plus Ck-Mb Item #65045 (G)JHW · Traditional | Harleco | 06/25/1981SE |
| K811573 | Cardiozyme Plus Ck-Mb Item #65045JHW · Traditional | Harleco | 06/25/1981SE |
| K810905 | Isomune-CkJHW · Traditional | Hoffmann-La Roche, Inc. | 04/14/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | The Dow Chemical Co. | 04/14/1981SE |
| K803168 | Cardio Zyme Plus Ck-Mb #65045JHW · Traditional | Harleco | 01/09/1981SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | Macomb Chemical Co. | 01/11/1980SE |
| K782015 | A-Gent Ck-MbJHW · Traditional | Abbott Laboratories | 02/01/1979SE |
| K781124 | CPK Isoenzyme ReagentJHW · Traditional | Electrophoresis Corp. of America | 08/10/1978SE |
| K772172 | Dynazyme TM II Cardiak-MbJHW · Traditional | J.T. Baker Chemical Co. | 12/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1224-2018 Class II | PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients…A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or… | Zimmer Biomet, Inc. | 12/12/2017Terminated |
| Z-2649-2017 Class III | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control…Incorrect control range in product labeling | Medtest Holdings, Inc. | 11/22/2010Terminated |