Cleared Traditional

AVL OPTI CRITICAL CARE ANALYZER

K974784 · Avl Scientific Corp. · Chemistry
Feb 1998
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K974784 is an FDA 510(k) clearance for the AVL OPTI CRITICAL CARE 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 February 24, 1998, 64 days after receiving the submission on December 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K974784 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1997
Decision Date February 24, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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