510(k) K962675 ยท GJT Plasma, Coagulation Factor Deficient
STA - LIATEST VWF TEST KIT
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Oct 25, 1996 |
| Received | Jul 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962675
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2013 | Diagnostica Stago, Inc. Vial Label:
1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago
2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago
3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago
Model, catalogue, number 00 Terminated |
GJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.