510(k) K052124 ยท GJS Test, Time, Prothrombin
ACTICLOT, MODEL 824
| Applicant | American Diagnostica, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Aug 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2007 | American Diagnostica, Inc. American Diagnostica Inc. ACTICLOT dPT
Reference 824 in vitro diagnostic Terminated |
GIR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.