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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK041748
Test Name AZOG One Step hCG Pregnacy Test Midstream (Urine)  
Manufacturer NameAZOG, INC.
Consumer Information Phone Number(866)865-4881
Test TypeUrine hCG by visual color comparison tests
Effective Date02/14/2005
Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K041748
Device Name AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
Applicant
AZOG, INC.
1011 US HWY 22
PHILLIPSBURG,  NJ  08865
Applicant Contact AZUBUIKE OGALA
Correspondent
AZOG, INC.
1011 US HWY 22
PHILLIPSBURG,  NJ  08865
Correspondent Contact AZUBUIKE OGALA
Regulation Number862.1155
Classification Product Code
LCX  
Date Received06/29/2004
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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