510(k) K912748 ยท LCP Assay, Glycosylated Hemoglobin
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
| Applicant | Binax, Inc., S. Portland ME, US |
| Decision | Substantially Equivalent, Oct 31, 1991 |
| Received | Jun 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912748
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.