Name: Predicase
Price: 199 USD

K-number	K171664
Device name	Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
Applicant	Bio-Rad Laboratories, Inc.
Product code	GKA
Device class	Class II
Decision date	Sep 13, 2017
Decision	Substantially Equivalent
Regulation	864.7415

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Source

View the full FDA submission: accessdata.fda.gov

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Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

Everything you need for a 510(k) submission. Nothing you don't.