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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK123050
Test Name EGENS One Step HCG Urine Pregnancy Test Kit (Strip)  
Manufacturer NameNANTONG BIOTECHNOLOGY CO., LTD.
Consumer Information Phone Number(855)397-6411
Test TypehCG, Urine
Effective Date02/11/2013
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K123050
Device Name EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
Applicant
NANTONG BIOTECHNOLOGY CO., LTD.
12828 DOE LANE
GAITHERSBURG,  MD  20878
Applicant Contact JOE XIA
Correspondent
NANTONG BIOTECHNOLOGY CO., LTD.
12828 DOE LANE
GAITHERSBURG,  MD  20878
Correspondent Contact JOE XIA
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received09/28/2012
Decision Date 02/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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