EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

Kit, Test, Pregnancy, Hcg, Over The Counter

NANTONG BIOTECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Nantong Biotechnology Co., Ltd. with the FDA for Egens One Step Hcg Urine Pregnancy Test Kit(s) (strip, Cassette, Midstream I And Midstream Ii).

Pre-market Notification Details

Device IDK123050
510k NumberK123050
Device Name:EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant NANTONG BIOTECHNOLOGY CO., LTD. 12828 DOE LANE Gaithersburg,  MD  20878
ContactJoe Xia
CorrespondentJoe Xia
NANTONG BIOTECHNOLOGY CO., LTD. 12828 DOE LANE Gaithersburg,  MD  20878
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-28
Decision Date2013-02-05
Summary:summary

NIH GUDID Devices

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