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FDA 510(k) Application Details - K202739
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K202739
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong
Longgang District
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Yiqing Feng
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2020
Decision Date
08/12/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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