Cleared Traditional

LIQUID GLUCOSE (OXIDASE) REAGENT SET

K970781 · Pointe Scientific, Inc., · Chemistry
Apr 1997
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K970781 is an FDA 510(k) clearance for the LIQUID GLUCOSE (OXIDASE) REAGENT SET, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 21, 1997, 48 days after receiving the submission on March 4, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K970781 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1997
Decision Date April 21, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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