Cleared Traditional

PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO

K884864 · The Perkin-Elmer Corp. · Toxicology
Feb 1989
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K884864 is an FDA 510(k) clearance for the PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on February 10, 1989, 80 days after receiving the submission on November 22, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K884864 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1988
Decision Date February 10, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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