One Touch Basic/Profile/One Touch II Test Strips

510(k) Number

K031472 ↗

FDA product code

CGA

Device class

Class II

Regulation

21 CFR Part 862.1345

Advisory committee

Clinical Chemistry

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code CGA (Glucose Oxidase, Glucose).

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• GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS by DIAMOND DIAGNOSTICS Inc
• QUANTAI BG(TM) REAGENT STRIP by Quantai Biotronics, Inc.
• ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM by Selfcare, Inc.
• EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM by EPS BIO TECHNOLOGY CORP.
• VISION BG MONITOR by British-American Medical, Inc.
• PRECISION Q I D BLOOD GLUCOSE TEST STRIPS by Medisense, Inc.
• NOVOCHECK/CHECKPOINT/CONTROL SOLUTION by Garid, Inc.
• GLUCOSE-SUPER FAST 4983050 AND 4983500 by American Research Products Co.
• GLUCOSE REAGENT B6360-11 by American Scientific Products

• Onetouch Reveal

  Class II

  FDA 510(k) K132618 Active Cleared 16 Dec 2013

• One Touch Profile Complete Diabetes Tracking System

  Class II

  FDA 510(k) K950727 Active Cleared 1 Jun 1995

• One Touch II Meter

  Class II

  FDA 510(k) K895911 Active Cleared 8 Nov 1989

• Modification to One Touch Ultra Blood Glucose Monitoring System Open recall

  Class II

  FDA 510(k) K062195 Active Cleared 16 Aug 2006

See all devices from Lifescan, Inc. →