K192931

Substantially Equivalent

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

Applicant: Helena Laboratories, Corp.
Product code: GKA
Advisory panel: Hematology
Date received: 2019-10-17
Decision date: 2022-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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