Cleared Traditional

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

K192931 · Helena Laboratories, Corp. · Hematology

Apr 2022

Decision

915d

Days

Class 2

Risk

About This 510(k) Submission

K192931 is an FDA 510(k) clearance for the V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Helena Laboratories, Corp. (Beaumont, US). The FDA issued a Cleared decision on April 19, 2022, 915 days after receiving the submission on October 17, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number	K192931 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2019
Decision Date	April 19, 2022
Days to Decision	915 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF