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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
Models 83064, 83065, 83066, 83067
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 (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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