510(k) K946274 ยท LCP Assay, Glycosylated Hemoglobin
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jul 11, 1995 |
| Received | Dec 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946274
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.