Cleared Special

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

K050960 · Wallac OY · Chemistry
Jul 2005
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K050960 is an FDA 510(k) clearance for the MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L 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 July 11, 2005, 84 days after receiving the submission on April 18, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K050960 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2005
Decision Date July 11, 2005
Days to Decision 84 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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