510(k) K974564 ยท DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Dec 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974564
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.