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 Roche Diagnostics Corp., Abbott Laboratories and Apex BioTechnology Corp..

508
Total
508
Cleared
195d
Avg days
2001
Since
508 devices
73–96 of 508
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442
Abbott Laboratories
Chemistry · 112d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332
Abbott Laboratories
Chemistry · 115d
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531
Abbott Laboratories
Chemistry · 95d
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 May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585
Roche Diagnostics Corp.
Chemistry · 85d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395
Roche Diagnostics Corp.
Chemistry · 266d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620
Roche Diagnostics Corp.
Chemistry · 156d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814
Abbott Laboratories
Chemistry · 16d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628
Abbott Laboratories
Chemistry · 15d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845
Abbott Laboratories
Chemistry · 28d
Cleared Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Jul 03, 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843
Medline Industries, Inc.
Chemistry · 17d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
K023256
Abbott Laboratories
Chemistry · 205d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
K022182
Abbott Laboratories
Chemistry · 68d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975
Abbott Laboratories
Chemistry · 176d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240
Medline Industries, Inc.
Chemistry · 143d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738
Roche Diagnostics Corp.
Chemistry · 15d