510(k) K972640 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Jul 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972640
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.