Cleared Traditional

K914841 - CHROMATOGRAPHY CLINICAL USE 75JQR
(FDA 510(k) Clearance)

Dec 1991
Decision
46d
Days
Class 1
Risk

K914841 is an FDA 510(k) clearance for the CHROMATOGRAPHY CLINICAL USE 75JQR. This device is classified as a Apparatus, High Pressure Liquid Chromatography (Class I - General Controls, product code KIE).

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on December 10, 1991, 46 days after receiving the submission on October 25, 1991.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K914841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date December 10, 1991
Days to Decision 46 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

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