Cleared Traditional

CENTRIPREP 100

K900280 · Amicon, Inc. · Chemistry

Feb 1990

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K900280 is an FDA 510(k) clearance for the CENTRIPREP 100, a Electrode, Ion Selective (non-specified) (Class I — General Controls, product code JJP), submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on February 16, 1990, 29 days after receiving the submission on January 18, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K900280 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 1990
Decision Date	February 16, 1990
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—