510(k) K801422 ยท LCP Assay, Glycosylated Hemoglobin
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
| Applicant | Sandare Chemical Co., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 8, 1980 |
| Received | Jun 17, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801422
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.