ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K011479

Name: FDA 510(k) clearance K011479
Creator: U.S. Food and Drug Administration
Published: 2001-11-30

Substantially Equivalent

Inverness Medical Innovations, Inc.

FDA 510(k) clearance K011479 for ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2001-11-30. Applicant: Inverness Medical Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Inverness Medical Innovations, Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2001-05-14
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGA

view all

K252488 — ABL90 FLEX PLUS System2026-05-01
K210933 — YSI 2900C Biochemistry Analyzer2024-09-30
K220328 — EasyStat 3002024-07-26
K223179 — Cholestech LDX System2023-09-20
K223755 — i-STAT G cartridge with the i-STAT 1 System2023-09-11

More clearances from Inverness Medical Innovations, Inc.

view all

K071265 — SMARTCHECK INR SYSTEM2007-11-30
K071587 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY2007-07-30
K060133 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET2006-02-16
K053196 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)2005-12-16
K011616 — INDUO BLOOD GLUCOSE METER2001-06-21

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.