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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. E.
Princeton,  NJ  08540
Applicant Contact ROBERT F MARTIN
Correspondent
I-Stat Corp.
303 College Rd. E.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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