ClearanceBrief
510(k) K970176 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

HCG CONTROLS

ApplicantInternational Newtech Development, Inc., Richmond, B.C., CA
DecisionSubstantially Equivalent, Feb 6, 1997
ReceivedJan 17, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970176

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.