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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 K001256
Device Name CONTROL PLASMA N
Applicant
DADE BEHRING, INC.
PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact DONNA A WOLF
Correspondent
DADE BEHRING, INC.
PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact DONNA A WOLF
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received04/19/2000
Decision Date 05/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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