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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K890634
Device Name BERICHROM PROTEIN C KIT
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 Number864.7290
Classification Product Code
GGP  
Date Received02/08/1989
Decision Date 04/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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