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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 K023240
Device Name ST AIA-PACK CA 19-9
Applicant
TOSOH CORP.
73 COGWHEEL LN.
SEYMOUR,  CT  06483
Applicant Contact JUDITH E LOEBEL
Correspondent
TOSOH CORP.
73 COGWHEEL LN.
SEYMOUR,  CT  06483
Correspondent Contact JUDITH E LOEBEL
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Code
JIS  
Date Received09/27/2002
Decision Date 12/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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