ClearanceBrief
510(k) K000231 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

TRIAGE BNP CALIBRATION VERIFICATION CONTROLS

ApplicantBiosite Incorporated, San Diego CA, US
DecisionSubstantially Equivalent, Mar 2, 2000
ReceivedJan 27, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000231

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.