Cleared Traditional

K841891 - VARIAN 3300 & 3400 GAS CHROMATOGRAPHS
(FDA 510(k) Clearance)

K841891 · Varian Assoc., Inc. · Chemistry
Jul 1984
Decision
63d
Days
Class 1
Risk

K841891 is an FDA 510(k) clearance for the VARIAN 3300 & 3400 GAS CHROMATOGRAPHS, a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ), submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1984, 63 days after receiving the submission on May 7, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number K841891 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1984
Decision Date July 09, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code KZQ — Chromatography(gas), Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2250

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