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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, ion specific, potassium
510(k) Number K010061
Device Name DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Applicant Contact RICHARD M VAUGHT
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS   JJE  
Date Received01/08/2001
Decision Date 03/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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