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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K011478
Device Name I-STAT SYSTEM
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 Number862.1450
Classification Product Code
KHP  
Subsequent Product Codes
CGA   CGL   CHL  
Date Received05/14/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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