510(k) K901414 ยท LCP Assay, Glycosylated Hemoglobin
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 15, 1990 |
| Received | Mar 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901414
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.