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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
Applicant
CLINIQA CORPORATION
288 DISTRIBUTION STREET
SAN MARCOS,  CA  92078
Applicant Contact DAWN GAST
Correspondent
CLINIQA CORPORATION
288 DISTRIBUTION STREET
SAN MARCOS,  CA  92078
Correspondent 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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