Cleared Traditional

AVL OMNI ANALYZER

K972733 · Avl Scientific Corp. · Chemistry
Sep 1997
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K972733 is an FDA 510(k) clearance for the AVL OMNI ANALYZER, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on September 9, 1997, 50 days after receiving the submission on July 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K972733 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1997
Decision Date September 09, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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