Source document or public record
FDA 510(k) K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
FDA 510(k) index record K192931. Device: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control. Applicant as listed: Helena Laboratories, Corp.. Decision date: 2022-04-19.
Source
"device_name": "V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K192931.
Device name: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control. Applicant as listed: Helena Laboratories, Corp..
Decision date: 2022-04-19. Decision wording: Substantially Equivalent.
Product code: GKA. Regulation: 21 CFR 864.7415. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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