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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K921477
Device Name I-STAT(TM) LEVELS 1,2,3 CONTROLS
Applicant
I-Stat Corp.
436 Hazeldean Rd.
Kanata
Ontario K2l 1t9, Canada,  CA
Applicant Contact ROBERT F MARTIN
Correspondent
I-Stat Corp.
436 Hazeldean Rd.
Kanata
Ontario K2l 1t9, Canada,  CA
Correspondent Contact ROBERT F MARTIN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/30/1992
Decision Date 11/02/1992
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
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