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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K860894
Device Name BEHRING NEPHELOMETER SYSTEM
Applicant
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/10/1986
Decision Date 04/15/1986
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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