510(k) K011933 ยท LCP Assay, Glycosylated Hemoglobin
GLYCOSAL II HBA 1C TEST
| Applicant | Provalis Diagnostics , Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Nov 2, 2001 |
| Received | Jun 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011933
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.