Cleared Traditional

K870690 - CENTRIPREP CONCENTRATOR
(FDA 510(k) Clearance)

K870690 · Amicon, Inc. · Chemistry device

Mar 1987

Decision

28d

Days

Class 1

Risk

K870690 is an FDA 510(k) clearance for the CENTRIPREP CONCENTRATOR. This device is classified as a Clinical Sample Concentrator (Class I - General Controls, product code JJH).

Submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on March 19, 1987, 28 days after receiving the submission on February 19, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number	K870690 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 19, 1987
Decision Date	March 19, 1987
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—