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FDA 510(k) Application Details - K223722
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K223722
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Mio Labs Inc.
#1023, ZGC Innovation Center, 4500 Great America Pkwy
Santa Clara, CA 95054 US
Other 510(k) Applications for this Company
Contact
Mark Qian
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
12/12/2022
Decision Date
06/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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