510(k) K981174 ยท GJT Plasma, Coagulation Factor Deficient
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
| Applicant | Precision Biologicals, Inc., Dartmouth, Nova Scotia, CA |
| Decision | Substantially Equivalent, Jan 13, 1999 |
| Received | Apr 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981174
No recall in the FDA data names this 510(k).
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