ClearanceBrief
510(k) K963934 ยท MMI Immunoassay Method, Troponin Subunit

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

ApplicantBio-Rad Laboratories, Inc., Chaska MN, US
DecisionSubstantially Equivalent, Dec 16, 1996
ReceivedOct 1, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K963934

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.