510(k) K912468 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
LIATEST PROTEIN S KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 2, 1991 |
| Received | Jun 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2007 | Diagnostica Stago, Inc. STA Liatest Free Protein S
For in vitro diagnostic use.
2-8 degrees C
Distributed in the USA by:
Diagnostica Stago, Inc.
5 Century Drive
Parsippany, NJ
Phone 800-abc coag
1 - 6 x 5 ml Buffer
2 - 6 x Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.