510(k) K013492 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
IMUBIND TPA ELISA, MODEL 860
| Applicant | American Diagnostica, Inc., Greenwich CT, US |
| Decision | Substantially Equivalent, Mar 13, 2002 |
| Received | Oct 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013492
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.