Cleared Traditional

VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM

K851945 · Varian Assoc., Inc. · Chemistry
May 1985
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K851945 is an FDA 510(k) clearance for the VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 24, 1985, 21 days after receiving the submission on May 3, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K851945 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1985
Decision Date May 24, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KZR — Chromatography (liquid, Gel), Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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