Cleared Traditional

AVL MODEL 986 ELECTROLYTE ANALYZER

K883240 · Avl Scientific Corp. · Chemistry
Sep 1988
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K883240 is an FDA 510(k) clearance for the AVL MODEL 986 ELECTROLYTE ANALYZER, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on September 22, 1988, 52 days after receiving the submission on August 1, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K883240 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1988
Decision Date September 22, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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