ClearanceBrief
510(k) K060027 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

ApplicantBiokit, S.A., Barcelona, ES
DecisionSubstantially Equivalent, Jan 26, 2006
ReceivedJan 4, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060027

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.