Cleared Traditional

GLUCOSE OXIDASE REAGENT

K870616 · Intersect Systems, Inc. · Chemistry
Mar 1987
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K870616 is an FDA 510(k) clearance for the GLUCOSE OXIDASE REAGENT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on March 6, 1987, 22 days after receiving the submission on February 12, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K870616 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1987
Decision Date March 06, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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