ClearanceBrief
510(k) K981038 ยท GGP Test, Qualitative And Quantitative Factor Deficiency

COAMATIC FACTOR VIII

ApplicantInstrumentation Laboratory CO, Lexington MA, US
DecisionSubstantially Equivalent, Apr 16, 1998
ReceivedMar 19, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K981038

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.