MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K001427

Clearance details

Applicant

Selfcare, Inc.

Product code

Code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2000-05-05

Decision date

2000-06-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Waltham, MA, US

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• K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST2000-10-12
• K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM2000-08-07
• K002049 — INVERNESS MEDICAL EARLY PREGNANCY TEST2000-07-27
• K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2000-03-17
• K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM1999-11-12

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 →