Cleared Traditional

AVL 9180 ELECTROLYTE ANALYZER

K961458 · Avl Scientific Corp. · Chemistry
Jun 1996
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K961458 is an FDA 510(k) clearance for the AVL 9180 ELECTROLYTE 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 June 12, 1996, 58 days after receiving the submission on April 15, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K961458 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1996
Decision Date June 12, 1996
Days to Decision 58 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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