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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K920258
Device Name QBC FIBRINOGEN
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received01/21/1992
Decision Date 06/26/1992
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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