510(k) K071649— NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

Substantially Equivalent

Wallac OY

Clearance details

Applicant: Wallac OY
Product code: Code JIA
Advisory panel: Clinical Chemistry
Date received: 2007-06-18
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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