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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K010206
Device Name DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
Applicant
Dade Behring, Inc.
Glasco B500 M.S. 514
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact RICHARD M VAUGHT
Correspondent
Dade Behring, Inc.
Glasco B500 M.S. 514
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1160
Classification Product Code
KHS  
Date Received01/23/2001
Decision Date 03/16/2001
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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