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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K133002
Device Name i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Applicant
ABBOTT POINT OF CARE INC.
400 COLLEGE ROAD EAST
PRINCETON,  NJ  08540
Applicant Contact MELISSA ROBINSON
Correspondent
ABBOTT POINT OF CARE INC.
400 COLLEGE ROAD EAST
PRINCETON,  NJ  08540
Correspondent Contact MELISSA ROBINSON
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JJX  
Date Received09/24/2013
Decision Date 04/16/2015
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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