FIRST RESPONSE PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K030258
Device Name FIRST RESPONSE PREGNANCY TEST
Original Applicant
ARMKEL, LLC.
469 north harrison st.
princeton, 
NJ 
08540 -3510

Original Contact stephen c kolakowsky
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 01/24/2003
Decision Date 02/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No