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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 K894914
Device Name MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
Applicant
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact MICHAEL GROVES
Correspondent
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact MICHAEL GROVES
Regulation Number862.1665
Classification Product Code
JGS  
Date Received08/02/1989
Decision Date 10/16/1989
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
Recalls CDRH Recalls
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