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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 K912387
Device Name I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
Applicant
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact ROBERT F MARTIN
Correspondent
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact ROBERT F MARTIN
Regulation Number862.1665
Classification Product Code
JGS  
Date Received05/01/1991
Decision Date 07/01/1991
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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