ST AIA-PACK CA 19-9


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
Original Applicant
TOSOH CORP.
73 cogwheel ln.
seymour, 
CT 
06483

Original Contact judith e loebel
Regulation Number 866.6010
Classification Product Code
NIG  
Subsequent Product Code
JIS  
Date Received 09/27/2002
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