510(k) K031857 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 4, 2003 |
| Received | Jun 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031857
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.