A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY


Device Classification Name

urinary homocystine (nonquantitative) test system

510(k) Number K080851
Device Name A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
Applicant
ANTICANCER INC
7917 ostrow st.
san diego, 
CA 
92111

Applicant Contact yuying tan
Correspondent
ANTICANCER INC
7917 ostrow st.
san diego, 
CA 
92111

Correspodent Contact yuying tan
Regulation Number 862.1377
Classification Product Code
LPS  
Date Received 03/26/2008
Decision Date 10/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No