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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, sodium
510(k) Number K001154
Device Name I-STAT MODEL 200 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 Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CDS   CEM   CGA   CGL   CGZ  
CHL   JBP   JFP   JPI   KHP  
Date Received04/10/2000
Decision Date 04/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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