ClearanceBrief
510(k) K920927 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024

ApplicantHelena Laboratories, Beaumont TX, US
DecisionSubstantially Equivalent, Jun 19, 1992
ReceivedFeb 28, 1992
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K920927

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.