Cleared Special

ACTIVE RENIN IRMA

K061758 · Diagnostic Systems Laboratories, Inc. · Chemistry
Jul 2006
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K061758 is an FDA 510(k) clearance for the ACTIVE RENIN IRMA, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on July 28, 2006, 36 days after receiving the submission on June 22, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K061758 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2006
Decision Date July 28, 2006
Days to Decision 36 days
Submission Type Special
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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