510(k) K811567 ยท LCP Assay, Glycosylated Hemoglobin
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Sep 16, 1981 |
| Received | Jun 4, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811567
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.