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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1 Microglobulin, Antigen, Antiserum, Control
510(k) Number K933078
Device Name BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622 -8000
Applicant Contact WILLIAM RYAN
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622 -8000
Correspondent Contact WILLIAM RYAN
Regulation Number866.5400
Classification Product Code
MGA  
Date Received06/23/1993
Decision Date 01/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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