510(k) K010978 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
TINA-QUANT ALPHA-1 ANTITRYPSIN
| Applicant | Rochdiag, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Mar 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010978
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.