Atlas FDA

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k) clearance K111874 · decided 2012-02-16

Clearance details

K-number
K111874
Device name
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2011-07-01
Decision date
2012-02-16
Days to decision
230 days
Clearance type
Traditional
Product code
LFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Alameda, CA, 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.

RecordFirmDate
FreeStyle InsuLinx Blood Glucose Monotioring System (K152328)Abott Laboratories2015-09-17
ACCU-CHEK AVIVA EXPERT SYSTEM (K142089)Roche Diagnostics Corporation2014-12-17
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 Corporation2013-04-04
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 Corporation2012-12-20
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 Corporation2012-09-19
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307)Hmd Biomedical, Inc.2012-07-27
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)Bayer Healthcare, LLC2012-07-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032)Abbott Laboratories2026-05-11
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068)Abbott Laboratories2026-02-23
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056)Abbott Laboratories2026-02-12
ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067)Abbott Laboratories2026-02-12
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031)Abbott Laboratories2026-02-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03