PREGNANCY ONE STEP RAPID TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K103574
Device Name PREGNANCY ONE STEP RAPID TEST
Applicant
Lehnus & Associates Consulting
150 cherry lane rd.
east stroudsburg, 
PA 
18301 -8804

Applicant Contact gary lehnus
Correspondent
Lehnus & Associates Consulting
150 cherry lane rd.
east stroudsburg, 
PA 
18301 -8804

Correspodent Contact gary lehnus
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 12/06/2010
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No