510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011479Substantially Equivalent

One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System

Inverness Medical Innovations, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011479 is the FDA 510(k) clearance record for ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Inverness Medical Innovations, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 6 510(k) clearances for Inverness Medical Innovations, Inc., from to . As of , FDA records show no recalls naming K011479.

Clearance record

Decision date
Received
(200 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Inverness Medical Innovations, Inc. 51 Sawyer Rd., Suite 200, Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260