Cleared Traditional

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS

K123763 · Immunodiagnostic Systems , Ltd. · Chemistry
Dec 2013
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K123763 is an FDA 510(k) clearance for the IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on December 24, 2013, 382 days after receiving the submission on December 7, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K123763 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2012
Decision Date December 24, 2013
Days to Decision 382 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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