Cleared Traditional

AVL MODEL 985 ELECTROLYTE ANALYZER

K870657 · Avl Scientific Corp. · Chemistry
May 1987
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K870657 is an FDA 510(k) clearance for the AVL MODEL 985 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 May 12, 1987, 83 days after receiving the submission on February 18, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K870657 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1987
Decision Date May 12, 1987
Days to Decision 83 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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