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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K192931
Device Name V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
Applicant
Helena Laboratories, Corp.
1530 Lingbergh Dr.
Beaumont,  TX  77707
Applicant Contact Justin Padia
Correspondent
Helena Laboratories, Corp.
1530 Lingbergh Dr.
Beaumont,  TX  77707
Correspondent Contact Justin Padia
Regulation Number864.7415
Classification Product Code
GKA  
Subsequent Product Code
JBD  
Date Received10/17/2019
Decision Date 04/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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