GSP NEONATAL THYROXINE (T4)

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

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 Gsp Neonatal Thyroxine (t4).

Pre-market Notification Details

• Device ID: K103484
• 510k Number: K103484
• Device Name: GSP NEONATAL THYROXINE (T4)
• Classification: Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
• 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: KLI
• CFR Regulation Number: 862.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-26
• Decision Date: 2011-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438147312139	K103484	000