ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY


Device Classification Name

test, epithelial ovarian tumor-associated antigen (ca125)

510(k) Number K023597
Device Name ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
Original Applicant
BECKMAN COULTER, INC.
7330 carroll rd.
san diego, 
CA 
92121

Original Contact mara caler
Regulation Number 866.6010
Classification Product Code
LTK  
Date Received 10/28/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No