510(k) K010597 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Feb 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010597
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.