510(k) K050178 ยท LCP Assay, Glycosylated Hemoglobin
HBA1C ENZYMATIC ASSAY
| Applicant | General Atomics, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 28, 2005 |
| Received | Jan 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050178
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.