ST AIA-PACK CA 125 ENZYME IMMUNOASSAY


Device Classification Name

test, epithelial ovarian tumor-associated antigen (ca125)

510(k) Number K023891
Device Name ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
Original Applicant
TOSOH MEDICS, INC.
347 oyster point blvd.,
suite 201
san francisco, 
CA 
94080

Original Contact lois nakayama
Regulation Number 866.6010
Classification Product Code
LTK  
Date Received 11/22/2002
Decision Date 12/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No