ClearanceBrief
510(k) K984318 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05

ApplicantBio-Rad, Irvine CA, US
DecisionSubstantially Equivalent, Dec 15, 1998
ReceivedDec 3, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K984318

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.