ClearanceBrief
510(k) K970189 ยท KQJ System, Fibrinogen Determination

FIF TM

ApplicantPanbio, Inc., South Bend IN, US
DecisionSubstantially Equivalent, May 21, 1997
ReceivedJan 21, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970189

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.