510(k) K071002 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 21, 2007 |
| Received | Apr 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071002
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.