510(k) K821975 ยท DIF Drug Mixture Control Materials
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Aug 27, 1982 |
| Received | Jul 6, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821975
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.