ClearanceBrief
510(k) K130090 ยท JPA System, Multipurpose For In Vitro Coagulation Studies

STA COMPACT MAX

ApplicantDiagnostica Stago, Incorporated, Rome, IT
DecisionSubstantially Equivalent, Feb 12, 2013
ReceivedJan 14, 2013
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K130090

DateFirm and productCodeLinked 510(k)
May 10, 2023Diagnostica Stago, Inc.
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Open, Classified
JPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.