Cleared Traditional

WATERS 515 HPLC PUMP (515)

K964588 · Waters Corporation · Toxicology
Nov 1996
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K964588 is an FDA 510(k) clearance for the WATERS 515 HPLC PUMP (515), a Apparatus, High Pressure Liquid Chromatography (Class I — General Controls, product code KIE), submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on November 29, 1996, 14 days after receiving the submission on November 15, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K964588 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1996
Decision Date November 29, 1996
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

Similar Devices — KIE Apparatus, High Pressure Liquid Chromatography

All 24
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
K935666 · The Perkin-Elmer Corp. · Apr 1994
WATERS(TM) 996 PDA
K924347 · Millipore Corp. · Dec 1992
CHROMATOGRAPHY CLINICAL USE 75JQR
K914841 · Millipore Corp. · Dec 1991
EQUIPMENT/MATERIAL DECONTAMINATING KIT
K911299 · Rohm and Haas Co. · Apr 1991
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
K862506 · Millipore Corp. · Jul 1986
EMIT ANCILLARY REAGENTS
K844947 · Syva Co. · Jun 1985