ClearanceBrief
510(k) K121237 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE

ApplicantCliniqa Corporation, San Marcos CA, US
DecisionSubstantially Equivalent, May 18, 2012
ReceivedApr 24, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121237

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.