Waters 474 Scanning Flourescence Detector (474)

FDA 510(k) K962574 · Waters Corporation

Substantially Equivalent

510(k) numberK962574

Submission

Device name
Waters 474 Scanning Flourescence Detector (474)
Applicant
Waters Corporation
Milford, MA, US
Received
July 1, 1996
Decision date
July 22, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LEQ – Detectors, Electrochemical, Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Specialty
Clinical Chemistry

Other 510(k)s with product code LEQ

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K903231Coulochem IILEQ · Traditional Esa, Inc.09/27/1990SE
K864729Neurochemical AnalyzerLEQ · Traditional Esa, Inc.04/13/1987SE
K801439Model 5100 Electrochemical DetectorLEQ · Traditional Environmental Sciences Assoc., Inc.07/21/1980SE

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K964588Waters 515 HPLC Pump (515)KIE · Traditional 11/29/1996SE
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Questions and answers

When was Waters 474 Scanning Flourescence Detector (474) cleared by the FDA?

Waters 474 Scanning Flourescence Detector (474) (K962574) received a 510(k) decision of Substantially Equivalent on July 22, 1996, 21 days after the submission was received.

What is the product code of K962574?

The FDA product code is LEQ – Detectors, Electrochemical, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.