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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plasma, coagulation control
510(k) Number K120900
Device Name I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
Original Applicant
CLINIQA CORPORATION
288 distribution street
san marcos,  CA  92078
Original Contact dawn gast
Regulation Number864.5425
Classification Product Code
GGN  
Date Received03/26/2012
Decision Date 05/31/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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