Cleared Traditional

K960053 - SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
(FDA 510(k) Clearance)

K960053 · Selfcare, Inc. · Chemistry

Jun 1996

Decision

176d

Days

Class 2

Risk

K960053 is an FDA 510(k) clearance for the SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH 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 28, 1996, 176 days after receiving the submission on January 4, 1996.

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

Submission Details

510(k) Number	K960053 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 1996
Decision Date	June 28, 1996
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement