Cleared Traditional

ULTRAFREE-CL

K941326 · Millipore Corp. · Chemistry
May 1994
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K941326 is an FDA 510(k) clearance for the ULTRAFREE-CL, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on May 27, 1994, 70 days after receiving the submission on March 18, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number K941326 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1994
Decision Date May 27, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJH — Clinical Sample Concentrator
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2310