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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K031560
Device Name BAYER RAPIDLAB 1200 SYSTEM
Applicant
BAYER HEALTHCARE, LLC
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact MARY E GRAY
Correspondent
BAYER HEALTHCARE, LLC
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Correspondent Contact MARY E GRAY
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKR   JFP  
JGS   KHP  
Date Received05/19/2003
Decision Date 12/17/2003
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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