Cleared Traditional

URINARY METANEPHRINE KIT

K952919 · Bioanalytical Systems, Inc. · Chemistry

Sep 1995

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K952919 is an FDA 510(k) clearance for the URINARY METANEPHRINE 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 September 6, 1995, 72 days after receiving the submission on June 26, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number	K952919 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1995
Decision Date	September 06, 1995
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF