FDA 510(k) Application Details - K221869

Device Classification Name	More FDA Info for this Device
510(K) Number	K221869
Device Name	BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Applicant	Suzhou Sniper Medical Technologies Co., Ltd Unit 301, Building A6, Suzhou BioBAY, No. 218 Xinghu Street Suzhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Peng Zhang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2022
Decision Date	09/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review