ClearanceBrief
510(k) K852418 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)

ApplicantAmf Biological and Diagnostics Co., Seguin TX, US
DecisionSubstantially Equivalent, Jul 15, 1985
ReceivedJun 7, 1985
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K852418

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.