Cleared Traditional

GSP NEONATALGALT KIT, MODEL 3303-001U

K100101 · Perkinelmer, Inc. · Chemistry

Jun 2010

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K100101 is an FDA 510(k) clearance for the GSP NEONATALGALT KIT, MODEL 3303-001U, a Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (Class II — Special Controls, product code KQP), submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 11, 2010, 149 days after receiving the submission on January 13, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K100101 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2010
Decision Date	June 11, 2010
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	KQP — Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1315