510(k) K961824 ยท DCF Albumin, Antigen, Antiserum, Control
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jul 23, 1996 |
| Received | May 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961824
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.