510(k) K964294 ยท DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
| Applicant | Crestat Diagnostics, Inc., Murrieta CA, US |
| Decision | Substantially Equivalent, Aug 1, 1997 |
| Received | Oct 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964294
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.