Cleared Traditional

2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

K973074 · Waters Corporation · Toxicology
Oct 1997
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K973074 is an FDA 510(k) clearance for the 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on October 6, 1997, 49 days after receiving the submission on August 18, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K973074 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date October 06, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KZR — Chromatography (liquid, Gel), Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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