NBW · Class II · 21 CFR 862.1345

FDA Product Code NBW: System, Test, Blood Glucose, Over The Counter

FDA product code NBW covers over-the-counter blood glucose test systems for home use by people with diabetes.

These systems — comprising a meter and test strips — allow patients to measure their blood glucose level from a small fingertip blood sample in seconds. Results guide insulin dosing decisions, dietary choices, and the management of hypoglycemic and hyperglycemic episodes.

NBW devices are Class II medical devices, regulated under 21 CFR 862.1345 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Taidoc Technology Corporation, Abbott Diabetes Care, Inc. and Apex BioTechnology Corp..

509
Total
509
Cleared
195d
Avg days
2001
Since
509 devices
97–120 of 509
Cleared Jan 06, 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469
ACON Laboratories, Inc.
Chemistry · 230d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284
ACON Laboratories, Inc.
Chemistry · 318d
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086
ACON Laboratories, Inc.
Chemistry · 167d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013
Nova Biomedical Corporation
Chemistry · 189d
Cleared May 16, 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040
Taidoc Technology Corporation
Chemistry · 139d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089
Abbott Laboratories
Chemistry · 186d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614
Roche Diagnostics
Chemistry · 434d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558
Lifescan, Inc.
Chemistry · 349d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010
ACON Laboratories, Inc.
Chemistry · 78d
Cleared Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679
Roche Diagnostics
Chemistry · 126d
Cleared Aug 03, 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077
Taidoc Technology Corporation
Chemistry · 291d
Cleared Jul 06, 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649
Apex BioTechnology Corp.
Chemistry · 126d
Cleared May 25, 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K110074
Health & Life Co., Ltd.
Chemistry · 501d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568
Abbott Diabetes Care, Inc.
Chemistry · 31d
Cleared Mar 09, 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638
Nova Biomedical Corporation
Chemistry · 182d
Cleared Feb 06, 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
K111890
Taidoc Technology Corporation
Chemistry · 220d
Cleared Jan 17, 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098
Apex BioTechnology Corp.
Chemistry · 90d
Cleared Jan 06, 2012
GLUCOSE TEST SYSTEM
K113137
Roche Diagnostics
Chemistry · 74d
Cleared Dec 20, 2011
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926
Taidoc Technology Corporation
Chemistry · 529d
Cleared Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
K112275
Taidoc Technology Corporation
Chemistry · 129d
Cleared Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
K112963
Taidoc Technology Corporation
Chemistry · 48d
Cleared Sep 15, 2011
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
K102816
Apex BioTechnology Corp.
Chemistry · 352d