Cleared Traditional

K863102 - GLUCOMETER-E
(FDA 510(k) Clearance)

K863102 · J. D. Assoc. · Chemistry

Nov 1986

Decision

103d

Days

Class 2

Risk

K863102 is an FDA 510(k) clearance for the GLUCOMETER-E, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 24, 1986, 103 days after receiving the submission on August 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K863102 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1986
Decision Date	November 24, 1986
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—