510(k) K001392 ยท LCP Assay, Glycosylated Hemoglobin
GLYCOSAL HBA1C TEST
| Applicant | Provalis Diagnostics , Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | May 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001392
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.