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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
Recalls CDRH Recalls
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