Cleared Special

K990939 - FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
(FDA 510(k) Clearance)

K990939 · Selfcare, Inc. · Chemistry

Apr 1999

Decision

29d

Days

Class 2

Risk

K990939 is an FDA 510(k) clearance for the FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA).

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on April 20, 1999, 29 days after receiving the submission on March 22, 1999.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K990939 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1999
Decision Date	April 20, 1999
Days to Decision	29 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF