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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K940918
Device Name I-STAT 200 PORTABLE CLINICAL ANALYZER
Applicant
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact IMANTS R LAUKS
Correspondent
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact IMANTS R LAUKS
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Code
JGS  
Date Received02/25/1994
Decision Date 05/10/1994
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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