K-number	K192931
Device name	V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
Applicant	Helena Laboratories, Corp.
Product code	GKA
Device class	Class II
Decision date	Apr 19, 2022
Decision	Substantially Equivalent
Regulation	864.7415

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Source

View the full FDA submission: accessdata.fda.gov

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V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

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