ClearanceBrief
510(k) K132156 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

RANDOX CSF CONTROLS LEVELS 2 AND 3

ApplicantRandox Laboratories, Ltd., Crumlin, GB
DecisionSubstantially Equivalent, Oct 23, 2013
ReceivedJul 11, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K132156

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.