Cleared Traditional

GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U

K100682 · Wallac OY · Chemistry
Jul 2010
Decision
135d
Days
Class 1
Risk

About This 510(k) Submission

K100682 is an FDA 510(k) clearance for the GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Wallac OY (Indianapolis, US). The FDA issued a Cleared decision on July 23, 2010, 135 days after receiving the submission on March 10, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K100682 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2010
Decision Date July 23, 2010
Days to Decision 135 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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