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FDA 510(k) Application Details - K033038
Device Classification Name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
More FDA Info for this Device
510(K) Number
K033038
Device Name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
BRENT TABER
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Regulation Number
866.6010
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Classification Product Code
NIG
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More FDA Info for this Product Code
Date Received
09/29/2003
Decision Date
12/29/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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