AUTODELFIA NEONATAL IRT KIT

N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin

WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.

The following data is part of a premarket notification filed by Wallac Oy, A Subsidiary Of Perkinelmer, Inc. with the FDA for Autodelfia Neonatal Irt Kit.

Pre-market Notification Details

• Device ID: K110274
• 510k Number: K110274
• Device Name: AUTODELFIA NEONATAL IRT KIT
• Classification: N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
• Applicant: WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham, MA 02451
• Contact: Susan K Hamann
• Correspondent: Susan K Hamann; WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham, MA 02451
• Product Code: JNO
• CFR Regulation Number: 862.1725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-31
• Decision Date: 2011-06-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438147298785	K110274	000
06438147298716	K110274	000