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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, Calcium
510(k) Number K934642
Device Name I-STAT IONIZED CALCIUM TEST
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 Number862.1145
Classification Product Code
JFP  
Date Received09/21/1993
Decision Date 12/17/1993
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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