POLY STAT SERUM/URINE HCG TEST


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K030430
Device Name POLY STAT SERUM/URINE HCG TEST
Applicant
ALIDEX, INC.
12277 134th ct., n.e., #100
redmond, 
WA 
98052

Applicant Contact helen landicho
Correspondent
ALIDEX, INC.
12277 134th ct., n.e., #100
redmond, 
WA 
98052

Correspodent Contact helen landicho
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 02/10/2003
Decision Date 04/18/2003
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