510(k) K831500 ยท DIF Drug Mixture Control Materials
TRI-LEVEL TDM CONTROL & I II III
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jun 30, 1983 |
| Received | May 11, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831500
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.