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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 K974827
Device Name TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact JOHN F BRUNI
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact JOHN F BRUNI
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/24/1997
Decision Date 01/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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