Cleared Traditional

CISBIO RENIN RIA TEST

K062120 · Cis Bio International · Chemistry
Mar 2007
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K062120 is an FDA 510(k) clearance for the CISBIO RENIN RIA TEST, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Cis Bio International (East Stroudsburg, US). The FDA issued a Cleared decision on March 30, 2007, 248 days after receiving the submission on July 25, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K062120 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2006
Decision Date March 30, 2007
Days to Decision 248 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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