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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 K170316
Device Name ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
Applicant
Abbott Laboratories
Dept. 09aa, Bldg. Cp1-3, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Noah Lermer
Correspondent
Abbott Laboratories
Dept. 09aa, Bldg. Cp1-3, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Noah Lermer
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Code
JJE  
Date Received02/01/2017
Decision Date 10/19/2017
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
Recalls CDRH Recalls
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