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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Fitc, Antigen, Antiserum, Control
510(k) Number K964781
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact FRANK MARTE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact FRANK MARTE
Regulation Number866.5060
Classification Product Code
DDS  
Subsequent Product Code
JIX  
Date Received11/27/1996
Decision Date 05/09/1997
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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