DeviceClearance

Product code CGA— Clinical Chemistry

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Classification name
Glucose Oxidase, Glucose
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Total cleared
401
First cleared
Most recent

Market context for product code CGA

FDA has cleared 401 devices under product code CGA between 1976 and 2026, filed by 184 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CGA

Adverse events under product code CGA

product code CGA
Death
2
Malfunction
1,816
Total
1,818

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

Recent clearances under product code CGA

1–100 of 401

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