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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 the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-04-19 under 510(k) 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. The listed applicant is Helena Laboratories, Corp.. The 510(k) number is K192931.

When did V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control receive FDA 510(k) clearance?

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

Who is the listed applicant for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

The FDA 510(k) record lists Helena Laboratories, Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Helena Laboratories, Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebiaK222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)K180762CAPI 3 HEMOGLOBIN(E)SebiaK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.

Official Source

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

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