510(k) K963111 ยท GGW Test, Time, Partial Thromboplastin
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
| Applicant | Chromogenix AB, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 23, 1996 |
| Received | Aug 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963111
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.