ClearanceBrief
510(k) K970645 ยท GJA Test, Thrombin Time

BC THROMBIN REAGENT

ApplicantBehring Diagnostics, Inc., San Jose CA, US
DecisionSubstantially Equivalent, May 19, 1997
ReceivedFeb 20, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970645

DateFirm and productCodeLinked 510(k)
Oct 17, 2017Siemens Healthcare Diagnostics
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time
Terminated		 GJANone listed
Oct 5, 2004Dade Behring , Inc.
BC Thrombin Reagent . Thrombin Time Test
Terminated		 GJANone listed

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