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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name igg, antigen, antiserum, control
510(k) Number K965108
Device Name SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact KATHLEEN M JAKER
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact KATHLEEN M JAKER
Regulation Number866.5510
Classification Product Code
DEW  
Date Received12/20/1996
Decision Date 03/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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