510(k) K800357 ยท LAS Drug Specific Control Materials
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
| Applicant | Ortho Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 16, 1980 |
| Received | Feb 20, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800357
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.