510(k) K941616 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT TOTAL GHB PROGRAM
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Apr 14, 1995 |
| Received | Apr 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941616
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.