Cleared Special

K993632 - FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
(FDA 510(k) Clearance)

K993632 · Selfcare, Inc. · Immunology

Nov 1999

Decision

16d

Days

Class 2

Risk

K993632 is an FDA 510(k) clearance for the 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 November 12, 1999, 16 days after receiving the submission on October 27, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K993632 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 1999
Decision Date	November 12, 1999
Days to Decision	16 days
Submission Type	Special
Review Panel	Immunology (IM)
Summary	Summary PDF