GSP NEONATALGALT KIT, MODEL 3303-001U— 510(k) K100101

Substantially Equivalent

Perkinelmer, Inc.

FDA 510(k) clearance K100101 for GSP NEONATALGALT KIT, MODEL 3303-001U, Substantially Equivalent on 2010-06-11. Applicant: Perkinelmer, Inc..

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code KQP
Advisory panel: Clinical Chemistry
Date received: 2010-01-13
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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