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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K924403
Device Name CONTROL PLASMA N
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received08/31/1992
Decision Date 02/22/1994
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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