510(k) K861697 ยท LCP Assay, Glycosylated Hemoglobin
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
| Applicant | Awareness Technology, Inc., Palm City FL, US |
| Decision | Substantially Equivalent, Aug 19, 1986 |
| Received | May 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861697
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.