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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K012470
Device Name MODIFICATION TO N PROTEIN STANDARD SL
Applicant
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/02/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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