510(k) K972214 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Jun 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972214
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.