510(k) K964766 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 25, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964766
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.