Cleared Traditional

RENAK

K831694 · Hoffmann-La Roche, Inc. · Chemistry
Jul 1983
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K831694 is an FDA 510(k) clearance for the RENAK, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 56 days after receiving the submission on May 24, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K831694 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1983
Decision Date July 19, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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