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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 K892223
Device Name BEHRING NEPHELOMETER 100
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOHN W HUFHWA
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOHN W HUFHWA
Regulation Number866.4540
Classification Product Code
JZW  
Date Received04/03/1989
Decision Date 05/04/1989
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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