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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bcr/Abl1 Monitoring Test
510(k) Number K221869
Device Name BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Applicant
Suzhou Sniper Medical Technologies Co., Ltd.
Unit 301, Bldg. A6, Suzhou Biobay, # 218 Xinghu St.
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Peng Zhang
Correspondent
Sinow Medical AS
Hoyteknologisenteret, Thormohlens Gate 55
Bergen,  NO 5006
Correspondent Contact Huifang Zhao
Regulation Number866.6060
Classification Product Code
OYX  
Subsequent Product Code
PHG  
Date Received06/28/2022
Decision Date 09/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Molecular Genetics
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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