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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, rheumatoid factor
510(k) Number K963048
Device Name IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact ANNETTE HELLIE
Regulation Number866.5775
Classification Product Code
DHR  
Date Received08/06/1996
Decision Date 11/04/1996
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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