ClearanceBrief
510(k) K253658 · JPA System, Multipurpose For In Vitro Coagulation Studies

STA Satellite Max®

ApplicantDiagnostica Stago, Inc., Parsippany NJ, US
DecisionSubstantially Equivalent, Apr 27, 2026
ReceivedNov 20, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253658

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.