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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 K963868
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
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 Number866.5510
Classification Product Code
DEW  
Subsequent Product Codes
CZP   DFT   JIX  
Date Received09/26/1996
Decision Date 02/10/1997
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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