Cleared Traditional

AUTODELFIA NEONATAL IRT KIT

K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Chemistry

Jun 2011

Decision

130d

Days

Class 1

Risk

About This 510(k) Submission

K110274 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT KIT, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on June 10, 2011, 130 days after receiving the submission on January 31, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number	K110274 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2011
Decision Date	June 10, 2011
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF