GSP NEONATAL BIOTINIDASE KIT— 510(k) K131284

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K131284 for GSP NEONATAL BIOTINIDASE KIT, Substantially Equivalent on 2013-11-14. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code NAK
Advisory panel: Clinical Chemistry
Date received: 2013-05-06
Decision date: 2013-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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