Cleared Traditional

SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)

K864267 · Millipore Corp. · Chemistry
Jan 1987
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K864267 is an FDA 510(k) clearance for the SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY), a Columns, Liquid Chromatography (Class I — General Controls, product code DPM), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on January 9, 1987, 72 days after receiving the submission on October 29, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K864267 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1986
Decision Date January 09, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code DPM — Columns, Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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