ClearanceBrief
510(k) K012243 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL

ApplicantHematronix, Inc., Benicia CA, US
DecisionSubstantially Equivalent, Aug 20, 2001
ReceivedJul 17, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012243

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.