Cleared Traditional

DELFIA CORTISOL KIT

K930732 · Wallac OY · Chemistry
Jul 1993
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K930732 is an FDA 510(k) clearance for the DELFIA CORTISOL KIT, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on July 27, 1993, 166 days after receiving the submission on February 11, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K930732 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1993
Decision Date July 27, 1993
Days to Decision 166 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFT — Fluorometric, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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