Cleared Traditional

LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS

K130321 · Diasorin · Chemistry

Apr 2013

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K130321 is an FDA 510(k) clearance for the LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS, a Radioimmunoassay, Aldosterone (Class II — Special Controls, product code CJM), submitted by Diasorin (Stillwater, US). The FDA issued a Cleared decision on April 9, 2013, 60 days after receiving the submission on February 8, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number	K130321 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2013
Decision Date	April 09, 2013
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF