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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
Correspondent
Behring Diagnostics, Inc.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
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
Predetermined Change
Control Plan Authorized		 No
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