510(k) K831837 ยท LCP Assay, Glycosylated Hemoglobin
CLINOVATIVE II DIAGNOSTIC KIT
| Applicant | Pierce Chemical Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 1, 1983 |
| Received | Jun 7, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831837
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.