510(k) K921684 ยท GGW Test, Time, Partial Thromboplastin
PTT-LA TEST KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 9, 1992 |
| Received | Apr 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2005 | Diagnostica Stago, Inc. PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. Terminated |
GGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.