ClearanceBrief
510(k) K031607 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

ApplicantOrion Diagnostica, Div. Orion Corp., Espoo, FI
DecisionSubstantially Equivalent, Oct 10, 2003
ReceivedMay 22, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031607

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.