Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190579
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K190579
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
TaiDoc Technology Corporation
6F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City 24888 TW
Other 510(k) Applications for this Company
Contact
Sophia Wu
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
03/06/2019
Decision Date
06/04/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact