510(k) K972257 ยท DDQ Antigen, Antiserum, Control, Antithrombin Iii
N-ASSAY TIA ANTITHROMBIN III TEST KIT
| Applicant | Crestat Diagnostics, Inc., Weston CT, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Jun 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972257
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.