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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c-reactive protein, antigen, antiserum, and control
510(k) Number K040579
Device Name CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
Applicant
CHOLESTECH CORP.
3347 INVESTMENT BLVD.
HAYWARD,  CA  94545
Applicant Contact THOMAS E WORTHY
Correspondent
CHOLESTECH CORP.
3347 INVESTMENT BLVD.
HAYWARD,  CA  94545
Correspondent Contact THOMAS E WORTHY
Regulation Number866.5270
Classification Product Code
DCK  
Date Received03/04/2004
Decision Date 06/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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