510(k) K935613 ยท LCP Assay, Glycosylated Hemoglobin
RADIAS MONOCLONAL HBA 1C ASSAY
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Apr 5, 1994 |
| Received | Nov 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935613
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.