Cleared Traditional

K970707 - ELECT II BLOOD GLUCOSE MONITORING SYSTEM
(FDA 510(k) Clearance)

K970707 · Selfcare, Inc. · Chemistry

Jun 1997

Decision

114d

Days

Class 2

Risk

K970707 is an FDA 510(k) clearance for the ELECT II 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 June 20, 1997, 114 days after receiving the submission on February 26, 1997.

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

Submission Details

510(k) Number	K970707 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 1997
Decision Date	June 20, 1997
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF