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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Fibrinogen Control
510(k) Number K962407
Device Name N/T PROTEIN CONTROL PY
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number864.7340
Classification Product Code
GIL  
Subsequent Product Codes
DBA   DEM   GIT   JJX  
Date Received06/21/1996
Decision Date 07/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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