EASYCUP


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K023823
Device Name EASYCUP
Original Applicant
ZER HITECH
1308 morningside park dr.
alpharetta, 
GA 
30022

Original Contact jay mansour
Regulation Number 862.1155
Classification Product Code
JHI  
Subsequent Product Code
LCX  
Date Received 11/15/2002
Decision Date 05/22/2003
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