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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K964368
Device Name ELECSYS CEA ASSAY
Original Applicant
BOEHRINGER MANNHEIM CORP.
2400 bisso ln.
concord,  CA  94524
Original Contact mary koning
Regulation Number862.1150
Classification Product Code
JIT  
Date Received11/01/1996
Decision Date 06/16/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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