510(k) K103557 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Apr 27, 2011 |
| Received | Dec 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103557
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.