Cleared Traditional

COLUMNS LIQUID CHROMATOGRAPHY DPM

K905538 · Millpore Corp. · Chemistry

Jan 1991

Decision

45d

Days

Class 1

Risk

About This 510(k) Submission

K905538 is an FDA 510(k) clearance for the COLUMNS LIQUID CHROMATOGRAPHY DPM, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by Millpore Corp. (Milford, US). The FDA issued a Cleared decision on January 25, 1991, 45 days after receiving the submission on December 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number	K905538 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 1990
Decision Date	January 25, 1991
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—