Cleared Traditional

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

K014173 · Beckman Coulter, Inc. · Toxicology
Feb 2002
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K014173 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 15, 2002, 57 days after receiving the submission on December 20, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K014173 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2001
Decision Date February 15, 2002
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKJ — Colorimetry, Salicylate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3830

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