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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K001387
Device Name I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
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 Number862.1345
Classification Product Code
CGA  
Date Received05/02/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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