Cleared Traditional

EMIT ANCILLARY REAGENTS

K844947 · Syva Co. · Toxicology
Jun 1985
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K844947 is an FDA 510(k) clearance for the EMIT ANCILLARY REAGENTS, a Apparatus, High Pressure Liquid Chromatography (Class I — General Controls, product code KIE), submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 28, 1985, 190 days after receiving the submission on December 20, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K844947 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1984
Decision Date June 28, 1985
Days to Decision 190 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KIE — Apparatus, High Pressure Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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