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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 K974110
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Correspondent Contact ANNETTE HELLIE
Regulation Number864.7060
Classification Product Code
JBQ  
Subsequent Product Code
DDQ  
Date Received10/31/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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