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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 K914890
Device Name N/T PROTEIN CONTROL UY
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/31/1991
Decision Date 02/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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