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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K250073
Device Name Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Applicant
Tosoh Bioscience, Inc.
3600 Gantz Rd.
Grove City,  OH  43123
Applicant Contact Corike Nuibe
Correspondent
Tosoh Bioscience, Inc.
3600 Gantz Rd.
Grove City,  OH  43123
Correspondent Contact Corike Nuibe
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received01/10/2025
Decision Date 10/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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