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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
510(k) Number K033038
Device Name GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact BRENT TABER
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact BRENT TABER
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Code
JIT  
Date Received09/29/2003
Decision Date 12/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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