510(k) K063323 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
SPECTROLYSE PAI-1, MODEL 101201
| Applicant | American Diagnostica, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Aug 15, 2007 |
| Received | Nov 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2012 | Sekisui Diagnostics Llc Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma.
Catalog # 101201.
Spectrolyse PAI-1 is in Terminated |
GGP | None listed |
| Sep 20, 2012 | Sekisui Diagnostics Llc Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma.
Catalog Number: 101201
For the determinatio Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.