Cleared Traditional

SIGMA 300 GAS CHROMATROGRAPH

K830147 · The Perkin-Elmer Corp. · Toxicology
Feb 1983
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K830147 is an FDA 510(k) clearance for the SIGMA 300 GAS CHROMATROGRAPH, a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983, 21 days after receiving the submission on January 17, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number K830147 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1983
Decision Date February 07, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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