ClearanceBrief
510(k) K060162 ยท JPA System, Multipurpose For In Vitro Coagulation Studies

ACL ELITE; ACL ELITE PRO

ApplicantInstrumentation Laboratory CO, Bedford MA, US
DecisionSubstantially Equivalent, Feb 21, 2006
ReceivedJan 23, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K060162

DateFirm and productCodeLinked 510(k)
Dec 27, 2010Instrumentation Laboratory Co.
ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
Terminated		 JPANone listed
Dec 27, 2010Instrumentation Laboratory Co.
ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.
Terminated		 JPANone listed
Dec 27, 2010Instrumentation Laboratory Co.
ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
Terminated		 JPANone listed
Dec 27, 2010Instrumentation Laboratory Co.
ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Terminated		 JPANone listed
Dec 27, 2010Instrumentation Laboratory Co.
ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
Terminated		 JPANone listed

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