Cleared Special

MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

K001427 · Selfcare, Inc. · Chemistry
Jun 2000
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K001427 is an FDA 510(k) clearance for the MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on June 2, 2000, 28 days after receiving the submission on May 5, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K001427 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2000
Decision Date June 02, 2000
Days to Decision 28 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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