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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K221508
Device Name AnemoCheck Home
Applicant
Sanguina, Inc.
147 Technology Pkwy., Suite 100
Peachtree Corners,  GA  30092
Applicant Contact Cathryn Cambria
Correspondent
Sanguina, Inc.
147 Technology Pkwy., Suite 100
Peachtree Corners,  GA  30092
Correspondent Contact Cathryn Cambria
Regulation Number864.7500
Classification Product Code
KHG  
Date Received05/24/2022
Decision Date 09/29/2023
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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