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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K964695
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Applicant Contact FRANK MARTE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Correspondent Contact FRANK MARTE
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Code
JIX  
Date Received11/22/1996
Decision Date 04/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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