CLEARBLUE EASY PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K110433
Device Name CLEARBLUE EASY PREGNANCY TEST
Applicant
SPD DEVELOPMENT COMPANY LIMITED
stannard way
priory business park
bedford, bedfordshire, 

GB

mk44 3up

Applicant Contact tanya fair
Correspondent
SPD DEVELOPMENT COMPANY LIMITED
stannard way
priory business park
bedford, bedfordshire, 

GB

mk44 3up

Correspodent Contact tanya fair
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 02/15/2011
Decision Date 05/12/2011
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