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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K771669
Device Name DIAG. KIT FOR TOTAL ANTITHROMBIN III
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received09/01/1977
Decision Date 11/09/1977
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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