ClearanceBrief
510(k) K972129 ยท MJZ Kit, Direct Antigen, Positive Control

CHLAMYDIATROL AG

ApplicantBlackhawk Biosystems, Inc., San Ramon CA, US
DecisionSubstantially Equivalent, Aug 12, 1997
ReceivedJun 6, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K972129

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.