ClearanceBrief
510(k) K021022 ยท GGN Plasma, Coagulation Control

HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

ApplicantInstrumentation Laboratory CO, Bedford MA, US
DecisionSubstantially Equivalent, May 14, 2002
ReceivedMar 29, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K021022

DateFirm and productCodeLinked 510(k)
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Terminated		 GGNNone listed
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Terminated		 GGNNone listed
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Terminated		 GGNNone listed

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