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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Prothrombin Consumption
510(k) Number K803081
Device Name QUANTICHECK CONTROL PLASMA
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number864.7720
Classification Product Code
GGQ  
Date Received12/05/1980
Decision Date 03/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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