Cleared Special

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

K042425 · Wallac OY · Chemistry
Sep 2004
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K042425 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 September 30, 2004, 22 days after receiving the submission on September 8, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K042425 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2004
Decision Date September 30, 2004
Days to Decision 22 days
Submission Type Special
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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