ClearanceBrief
510(k) K990296 ยท GJT Plasma, Coagulation Factor Deficient

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

ApplicantPrecision Biologic, Dartmouth, N.S., CA
DecisionSubstantially Equivalent, Mar 18, 1999
ReceivedJan 28, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K990296

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.