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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K031683
Device Name TOX AMMONIA CALIBRATOR
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/30/2003
Decision Date 08/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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