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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nephelometer
510(k) Number K761234
Device Name BEHRING LASER NEPHELOMETER
Applicant
BEHRING DIAGNOSTICS, INC.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent
BEHRING DIAGNOSTICS, INC.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Regulation Number866.4540
Classification Product Code
JZW  
Date Received06/07/1990
Decision Date 06/07/1990
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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