ClearanceBrief
510(k) K012117 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001

ApplicantMaine Standards Co., Windham ME, US
DecisionSubstantially Equivalent, Aug 20, 2001
ReceivedJul 6, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012117

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.