510(k) K954656 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ROCHE CONTROL SERUM P
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 21, 1995 |
| Received | Oct 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954656
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.