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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K193053
FOIA Releasable 510(k) K193053
Device Name Tina-quant Hemoglobin A1cDx Gen.3
Applicant
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Leslie Patterson
Correspondent
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Leslie Patterson
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received11/01/2019
Decision Date 03/26/2020
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
Predetermined Change
Control Plan Authorized		 No
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