Cleared Traditional

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

K081922 · Wallac OY · Chemistry
Apr 2009
Decision
283d
Days
Class 1
Risk

About This 510(k) Submission

K081922 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on April 16, 2009, 283 days after receiving the submission on July 7, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K081922 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2008
Decision Date April 16, 2009
Days to Decision 283 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLX — Radioimmunoassay, 17-hydroxyprogesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1395

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