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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hexokinase, glucose
510(k) Number K191899
Device Name Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
Applicant
Roche Diagnostics
9115 Hague Road
indianapolis,  IN  46250
Applicant Contact khoa tran
Correspondent
Roche Diagnostics
9115 Hague Road
indianapolis,  IN  46250
Correspondent Contact khoa tran
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
JGS   JJE   JLW  
Date Received07/16/2019
Decision Date 08/16/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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