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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 K071319
Device Name I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
Applicant
Bio-Rad, Diagnostics Grp.
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact MARIA ZEBALLOS
Correspondent
Bio-Rad, Diagnostics Grp.
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact MARIA ZEBALLOS
Regulation Number864.5425
Classification Product Code
GGN  
Date Received05/10/2007
Decision Date 06/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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