Cleared Traditional

PLASMA CATECHOLAMINE KIT

K972167 · Bioanalytical Systems, Inc. · Chemistry

Aug 1997

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K972167 is an FDA 510(k) clearance for the PLASMA CATECHOLAMINE KIT, a Chromatographic/fluorometric Method, Catecholamines (Class I — General Controls, product code CHQ), submitted by Bioanalytical Systems, Inc. (West Lafayette, US). The FDA issued a Cleared decision on August 4, 1997, 56 days after receiving the submission on June 9, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number	K972167 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1997
Decision Date	August 04, 1997
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF