510(k) K780002 ยท JBQ Antithrombin Iii Quantitation
ANTITHROMBIN III ASSAY
| Applicant | Ortho Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 31, 1978 |
| Received | Dec 30, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780002
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.