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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
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