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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 K800656
Device Name A-GENT QUANTICHROM THROMBIGEN-E
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 Received03/25/1980
Decision Date 05/30/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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