ClearanceBrief
510(k) K970778 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

ApplicantMore Diagnostics, Los Osos CA, US
DecisionSubstantially Equivalent, Apr 17, 1997
ReceivedMar 4, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970778

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.