510(k) K013168 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
| Applicant | American Diagnostica, Inc., Greenwich CT, US |
| Decision | Substantially Equivalent, Mar 7, 2002 |
| Received | Sep 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2010 | American Diagnostica, Inc. REF 822 IMUBIND(R) Plasma PAI-1 ELISA
The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.