ClearanceBrief
510(k) K982089 ยท LFR Glucose Dehydrogenase, Glucose

ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS

ApplicantBoehringer Mannheim Corp., Indianapolis IN, US
DecisionSubstantially Equivalent, Sep 3, 1998
ReceivedJun 15, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K982089

DateFirm and productCodeLinked 510(k)
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or 100s) 03144917001, 03144704001, 03145263001 and International Reference nos. 12030551001, 12030578001 and 120
Terminated		 LFRNone listed
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, 03145263001, (sold within the United States) and 12030551001, 12030578001 and 12030586001 (sold outside of th
Terminated		 LFRNone listed
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 12030543047
Terminated		 LFRNone listed
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside of the United States).
Terminated		 LFRNone listed
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States).
Terminated		 LFRNone listed
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
Terminated		 LFRNone listed
Apr 9, 2003Roche Diagnostics Corp.
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
Terminated		 LFRNone listed

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