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

FDA 510(k) clearance K982089 · decided 1998-09-03

Clearance details

K-number: K982089
Device name: ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
Applicant: Boehringer Mannheim Corp.
Decision: Substantially Equivalent
Date received: 1998-06-15
Decision date: 1998-09-03
Days to decision: 80 days
Clearance type: Traditional
Product code: LFR
Device class: 2
Regulation number: 862.1345
Medical specialty: Clinical Chemistry
Advisory committee: Clinical Chemistry
Location: Indianapolis, IN, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
FreeStyle InsuLinx Blood Glucose Monotioring System (K152328)	Abott Laboratories	2015-09-17
ACCU-CHEK AVIVA EXPERT SYSTEM (K142089)	Roche Diagnostics Corporation	2014-12-17
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM (K133537)	Eps Bio Technology Corp.	2014-04-28
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (K131727)	Ceragem Medisys, Inc.	2014-02-28
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366)	Roche Diagnostics Operations, Inc.	2013-10-11
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688)	Nova Biomedical Corporation	2013-04-04
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433)	Hmd Biomedical, Inc.	2013-02-14
NOVA ONE BLOOD GLUCOSE MONITOR (K122435)	Nova Biomedical Corporation	2012-12-20
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K113314)	Hmd Biomedical, Inc.	2012-11-09
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (K121224)	Taidoc Technology Corporation	2012-09-19
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307)	Hmd Biomedical, Inc.	2012-07-27
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)	Bayer Healthcare, LLC	2012-07-26

Record	Firm	Date
Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or recall (Z-1378-06)	Roche Diagnostics Corp.	2006-08-11
Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, recall (Z-0567-06)	Roche Diagnostics Corp.	2006-02-28
Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 120306670 recall (Z-0568-06)	Roche Diagnostics Corp.	2006-02-28
Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold recall (Z-0569-06)	Roche Diagnostics Corp.	2006-02-28
Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold recall (Z-0570-06)	Roche Diagnostics Corp.	2006-02-28
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and recall (Z-0573-06)	Roche Diagnostics Corp.	2006-02-28
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966. recall (Z-0716-03)	Roche Diagnostics Corp.	2003-04-09