ClearanceBrief
510(k) K990608 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05

ApplicantBio-Rad, Irvine CA, US
DecisionSubstantially Equivalent, Mar 30, 1999
ReceivedFeb 24, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K990608

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.