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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lambda, antigen, antiserum, control
510(k) Number K902485
Device Name BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
brea,  CA  92622 -8000
Applicant Contact william t ryan
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
brea,  CA  92622 -8000
Correspondent Contact william t ryan
Regulation Number866.5550
Classification Product Code
DEH  
Date Received06/05/1990
Decision Date 06/21/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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