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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 K936081
Device Name I-STAT TESTS FOR ACID-BASE PARAMETERS
Applicant
I-Stat Corp.
436 Hazeldean Rd.
Kanata
Ontario K2l 1t9, Canada,  CA
Applicant Contact IMANTS R LAUKS
Correspondent
I-Stat Corp.
436 Hazeldean Rd.
Kanata
Ontario K2l 1t9, Canada,  CA
Correspondent Contact IMANTS R LAUKS
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/21/1993
Decision Date 02/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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