POLY STAT HCG DIPSTICK TEST


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K021386
Device Name POLY STAT HCG DIPSTICK TEST
Original Applicant
ALIDEX, INC.
12277 134th ct., n.e., #100
redmond, 
WA 
98052

Original Contact helen landicho
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 05/02/2002
Decision Date 08/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No