MID STREAM PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K023037
Device Name MID STREAM PREGNANCY TEST
Original Applicant
ADVANCED DIAGNOSTICS, INC.
801 montrose ave.
so. plainfield, 
NJ 
07080

Original Contact d.m. chouhan
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 09/12/2002
Decision Date 04/09/2003
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