Cleared Traditional

K820455 - CENTRIFREE MICROPARTITION SYSTEM
(FDA 510(k) Clearance)

K820455 · Amicon, Inc. · Chemistry device

Mar 1982

Decision

24d

Days

Class 1

Risk

K820455 is an FDA 510(k) clearance for the CENTRIFREE MICROPARTITION SYSTEM. This device is classified as a Unit, Filter, Membrane (Class I - General Controls, product code JRL).

Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982, 24 days after receiving the submission on February 19, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K820455 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 19, 1982
Decision Date	March 15, 1982
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—