Cleared Traditional

NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY

K950524 · Nichols Institute · Chemistry
May 1995
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K950524 is an FDA 510(k) clearance for the NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY, a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I — General Controls, product code JKC), submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on May 15, 1995, 105 days after receiving the submission on January 30, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1245.

Submission Details

510(k) Number K950524 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1995
Decision Date May 15, 1995
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1245

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