Cleared Traditional

K961985 - ELECT BLOOD GLUCOSE MONITORIG SYSTEM
(FDA 510(k) Clearance)

K961985 · Selfcare, Inc. · Chemistry

Sep 1996

Decision

107d

Days

Class 2

Risk

K961985 is an FDA 510(k) clearance for the ELECT BLOOD GLUCOSE MONITORIG 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 September 5, 1996, 107 days after receiving the submission on May 21, 1996.

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

Submission Details

510(k) Number	K961985 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1996
Decision Date	September 05, 1996
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF