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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K941912
Device Name N/T PROTEIN CONTROL SY/L, M, AND H
Applicant
Behring Diagnostics, Inc.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact NANCY M JOHANSEN
Correspondent
Behring Diagnostics, Inc.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact NANCY M JOHANSEN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/19/1994
Decision Date 06/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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