AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)


Device Classification Name

system, test, human chorionic gonadotropin

510(k) Number K022681
Device Name AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
Original Applicant
AZOG, INC.
1011 us hwy 22
phillipsburg, 
NJ 
08865

Original Contact azubuike ogala
Regulation Number 862.1155
Classification Product Code
DHA  
Date Received 08/12/2002
Decision Date 11/01/2002
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