510(k) K021194 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jul 29, 2002 |
| Received | Apr 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021194
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.