510(k) K971219 ยท GGN Plasma, Coagulation Control
CRYO CHECK INR VALIDATION SET
| Applicant | Precision Biologicals, Inc., Dartmouth, Nova Scotia, CA |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Apr 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971219
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.