510(k) K083729 ยท GGW Test, Time, Partial Thromboplastin
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
| Applicant | Aniara Diagnostica, LLC, Mason OH, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083729
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.