E.P.T. PREGNANCY TEST

Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K033658
Device Name E.P.T. PREGNANCY TEST
Applicant
UNIPATH LTD.
priory business park
bedford, 

GB

mk44 3up

Applicant Contact louise roberts
Correspondent
UNIPATH LTD.
priory business park
bedford, 

GB

mk44 3up

Correspodent Contact louise roberts
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 11/21/2003
Decision Date 01/16/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No