Cleared Traditional

LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT

K121944 · DiaSorin, Inc. · Chemistry
Jan 2013
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K121944 is an FDA 510(k) clearance for the LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on January 1, 2013, 182 days after receiving the submission on July 3, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K121944 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2012
Decision Date January 01, 2013
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIB — Radioimmunoassay, Angiotensin I And Renin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1085

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