Cleared Traditional

AVL OMNI ANALYZER

K945915 · Avl Scientific Corp. · Chemistry

Apr 1995

Decision

124d

Days

Class 1

Risk

About This 510(k) Submission

K945915 is an FDA 510(k) clearance for the AVL OMNI ANALYZER, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on April 5, 1995, 124 days after receiving the submission on December 2, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K945915 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1994
Decision Date	April 05, 1995
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JJC — Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2150