Cleared Traditional

GSP NEONATAL THYROXINE (T4)

K103484 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Chemistry
Apr 2011
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K103484 is an FDA 510(k) clearance for the GSP NEONATAL THYROXINE (T4), a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on April 22, 2011, 147 days after receiving the submission on November 26, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K103484 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2010
Decision Date April 22, 2011
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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