Cleared Traditional

CENTRICON -50 CONCENTRATOR

K930168 · Amicon, Inc. · Chemistry

Aug 1993

Decision

204d

Days

Class 1

Risk

About This 510(k) Submission

K930168 is an FDA 510(k) clearance for the CENTRICON -50 CONCENTRATOR, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on August 5, 1993, 204 days after receiving the submission on January 13, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number	K930168 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1993
Decision Date	August 05, 1993
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF