Cleared Traditional

IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers

K142994 · Immunodiagnostic Systems , Ltd. · Chemistry

Apr 2015

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

K142994 is an FDA 510(k) clearance for the IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers, a Radioimmunoassay, Aldosterone (Class II — Special Controls, product code CJM), submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on April 21, 2015, 187 days after receiving the submission on October 16, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number	K142994 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 2014
Decision Date	April 21, 2015
Days to Decision	187 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF