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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K063206
Device Name DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
Applicant
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact KATHLEEN DRAY- LYONS
Correspondent
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact KATHLEEN DRAY- LYONS
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIX   JJY  
Date Received10/23/2006
Decision Date 12/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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