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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K003503
Device Name N LATEX CYSTATIN C
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1225
Classification Product Code
NDY  
Date Received11/13/2000
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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