Cleared Traditional

GSP NEONATAL TOTAL GALACTOSE KIT

K133652 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Chemistry

Apr 2014

Decision

152d

Days

Class 1

Risk

About This 510(k) Submission

K133652 is an FDA 510(k) clearance for the GSP NEONATAL TOTAL GALACTOSE KIT, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on April 28, 2014, 152 days after receiving the submission on November 27, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number	K133652 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2013
Decision Date	April 28, 2014
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF