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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K053576
Device Name DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Applicant Contact GEORGE M PLUMMER
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
DDR  
Date Received12/22/2005
Decision Date 02/07/2006
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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