AMEDITECH IMMUTEST HCG PREGANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K023126
Device Name AMEDITECH IMMUTEST HCG PREGANCY TEST
Original Applicant
AMEDITECH, INC.
10340 camino santa fe
suites f-g
san diego, 
CA 
92121

Original Contact john wu
Regulation Number 862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received 09/19/2002
Decision Date 11/18/2002
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