Cleared Traditional

K943376 - OPERA SYSTEM
(FDA 510(k) Clearance)

K943376 · Miles, Inc. · Chemistry

Sep 1994

Decision

63d

Days

Class 1

Risk

K943376 is an FDA 510(k) clearance for the OPERA SYSTEM, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 14, 1994, 63 days after receiving the submission on July 13, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K943376 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1994
Decision Date	September 14, 1994
Days to Decision	63 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