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FDA 510(k)

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

K-Number: K192931 · 2022-04-19

ApplicantHelena Laboratories, Corp.
Decision Date2022-04-19
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is a medical device manufactured by Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-04-19 under approval number K192931. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is a medical device that received FDA 510(k) clearance on 2022-04-19. It is manufactured by Helena Laboratories, Corp.. The 510(k) number is K192931.

When was V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control approved by the FDA?

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control received FDA 510(k) clearance on 2022-04-19, under approval number K192931.

What company makes V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is manufactured by Helena Laboratories, Corp..

What is the FDA product code for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

The FDA product code for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is GKA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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