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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K000231
Device Name TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
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
JJX  
Date Received01/27/2000
Decision Date 03/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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