ClearanceBrief
510(k) K945908 ยท CFR Hexokinase, Glucose

GLUCOSE (HK) REAGENT (PROCEDURE NO.16)

ApplicantSigma Diagnostics, Inc., St. Louis MO, US
DecisionSubstantially Equivalent, May 8, 1995
ReceivedDec 2, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K945908

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.