510(k) K053603 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 9, 2006 |
| Received | Dec 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053603
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.