510(k) K892859 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
THE STAGO VIII DEFICIENT PLASMA KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 23, 1989 |
| Received | Apr 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2020 | Diagnostica Stago, Inc. STA - Deficient VIII, Product Code: 00725.
STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Co Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.