510(k) K190335— GSP Neonatal Total Galactose kit

Substantially Equivalent

Perkinelmer, Inc.

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code JIA
Advisory panel: Clinical Chemistry
Date received: 2019-02-14
Decision date: 2019-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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