510(k) K955450 ยท GFO Activated Partial Thromboplastin
PATHROMTIN SL
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Apr 19, 1996 |
| Received | Nov 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955450
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Dade Behring , Inc. Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials Terminated |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.