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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K922646
Device Name REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOSEPH KICEINA
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOSEPH KICEINA
Regulation Number862.1150
Classification Product Code
JIS  
Date Received06/03/1992
Decision Date 06/25/1993
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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