510(k) K943518 ยท GGN Plasma, Coagulation Control
STA SYSTEM CONTROL [N] + [P] KIT
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Mar 21, 1995 |
| Received | Jul 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2019 | Diagnostica Stago, Inc. STA SYSTEM CONROL N + P (ref. 00678) Terminated |
GGN | None listed |
| Feb 16, 2012 | Diagnostica Stago, Inc. STA - System Control N + P
Product Usage:
The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on Terminated |
GGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.