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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 Based, Enzymatic, Creatinine
510(k) Number K973292
Device Name I-STAT SYSTEM
Applicant
I-Stat Corp.
303 College Rd. E.
Princeton,  NJ  08540
Applicant Contact IMANTS R LAUKS
Correspondent
I-Stat Corp.
303 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact IMANTS R LAUKS
Regulation Number862.1225
Classification Product Code
CGL  
Date Received09/02/1997
Decision Date 10/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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