510(k) K160570 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Creatine Kinase
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis MD, US |
| Decision | Substantially Equivalent, May 25, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2024 | Roche Diagnostics Operations, Inc. Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma.
Catalog Number: 07190794 Open, Classified |
JHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.