V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control— 510(k) K192931

Substantially Equivalent

Helena Laboratories, Corp.

FDA 510(k) clearance K192931 for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control, Substantially Equivalent on 2022-04-19. Applicant: Helena Laboratories, Corp..

Clearance details

Applicant: Helena Laboratories, Corp.
Product code: 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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