Cleared Traditional

AVL OPTI CRITICAL CARE ANALYZER

K984299 · Avl Scientific Corp. · Chemistry
Dec 1998
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K984299 is an FDA 510(k) clearance for the AVL OPTI CRITICAL CARE ANALYZER, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on December 11, 1998, 10 days after receiving the submission on December 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K984299 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1998
Decision Date December 11, 1998
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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