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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 K012478
Device Name MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
Applicant
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Applicant Contact PAUL VANDERWERF
Correspondent
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Correspondent Contact PAUL VANDERWERF
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CDS   CEM   CGZ   CHA   JBP  
JGS   JPI   KHP  
Date Received08/02/2001
Decision Date 08/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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