INVERNESS MEDICAL EARLY PREGNANCY TEST


codes

Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K002049
Device Name INVERNESS MEDICAL EARLY PREGNANCY TEST
Original Applicant
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Original Contact carol a adiletto
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 07/03/2000
Decision Date 07/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No