GSP NEONATAL THYROXINE (T4)— 510(k) K103484

Substantially Equivalent

Wallac Oy, A Subsidiary of Perkinelmer, Inc.

FDA 510(k) clearance K103484 for GSP NEONATAL THYROXINE (T4), Substantially Equivalent on 2011-04-22. Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc..

Clearance details

Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Product code: Code KLI
Advisory panel: Clinical Chemistry
Date received: 2010-11-26
Decision date: 2011-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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