510(k) K813322 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 17, 1981 |
| Received | Nov 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813322
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.