ST AIA-PACK AFP ENZYME IMMUNOASSAY


Device Classification Name

kit, test,alpha-fetoprotein for testicular cancer

510(k) Number K023894
Device Name ST AIA-PACK AFP 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
LOJ  
Subsequent Product Code
JIS  
Date Received 11/22/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No