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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K011852
Device Name DIMENSION HAIC ASSAY, MODEL DF105
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
P.O. BOX 6101, BUILDING 500
NEWARK,  DE  19714
Applicant Contact Cathy Craft
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
P.O. BOX 6101, BUILDING 500
NEWARK,  DE  19714
Correspondent Contact Cathy Craft
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/12/2001
Decision Date 11/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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