AUTODELFIA NEONATAL IRT KIT— 510(k) K110274

Substantially Equivalent

Wallac Oy, A Subsidiary of Perkinelmer, Inc.

FDA 510(k) clearance K110274 for AUTODELFIA NEONATAL IRT KIT, Substantially Equivalent on 2011-06-10. Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc..

Clearance details

Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Product code: Code JNO
Advisory panel: Clinical Chemistry
Date received: 2011-01-31
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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