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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, cortisol
510(k) Number K050202
Device Name CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska,  MN  55318 1084
Original Contact brent taber
Regulation Number862.1205
Classification Product Code
CGR  
Subsequent Product Code
JIS  
Date Received01/28/2005
Decision Date 02/09/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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