GSP NEONATAL IRT KIT (3306-001U)— 510(k) K102419

Name: FDA 510(k) clearance K102419
Creator: U.S. Food and Drug Administration
Published: 2010-12-16

Substantially Equivalent

Wallac Oy, Subsidiary of Perkinelmer

FDA 510(k) clearance K102419 for GSP NEONATAL IRT KIT (3306-001U), Substantially Equivalent on 2010-12-16. Applicant: Wallac Oy, Subsidiary of Perkinelmer. Device class: 1.

Clearance details

Applicant: Wallac Oy, Subsidiary of Perkinelmer
Product code: Code JNO
Device class: Class 1
Regulation: 21 CFR 862.1725
Advisory panel: Clinical Chemistry
Date received: 2010-08-25
Decision date: 2010-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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