Cleared Traditional

SERIES 4 LIQUID CHROMATOGRAPH

K821219 · The Perkin-Elmer Corp. · Toxicology
May 1982
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K821219 is an FDA 510(k) clearance for the SERIES 4 LIQUID CHROMATOGRAPH, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 31 days after receiving the submission on April 27, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K821219 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date May 28, 1982
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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