Cleared Traditional

NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)

K011128 · Nichols Institute Diagnostics · Chemistry
Sep 2001
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K011128 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT), a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on September 6, 2001, 146 days after receiving the submission on April 13, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K011128 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2001
Decision Date September 06, 2001
Days to Decision 146 days
Submission Type Traditional
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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