Cleared Traditional

SYVA SOLID PHASE COLUMNS SYSTEM II

K861392 · Syva Co. · Chemistry
Jun 1986
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K861392 is an FDA 510(k) clearance for the SYVA SOLID PHASE COLUMNS SYSTEM II, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 13, 1986, 60 days after receiving the submission on April 14, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K861392 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1986
Decision Date June 13, 1986
Days to Decision 60 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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