Cleared Traditional

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

K032188 · Nichols Institute Diagnostics · Chemistry
Jul 2003
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K032188 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE ALDOSTERONE ASSAY, a Radioimmunoassay, Aldosterone (Class II — Special Controls, product code CJM), submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on July 31, 2003, 14 days after receiving the submission on July 17, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number K032188 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2003
Decision Date July 31, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJM — Radioimmunoassay, Aldosterone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1045

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