Cleared Traditional

CENTRICON CONCENTRATOR

K893733 · Amicon, Inc. · Chemistry
Jul 1989
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K893733 is an FDA 510(k) clearance for the CENTRICON 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 July 20, 1989, 64 days after receiving the submission on May 17, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number K893733 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1989
Decision Date July 20, 1989
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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