INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Kit, Test, Pregnancy, Hcg, Over The Counter

Innovita (Tangshan) Biological Technology Co., Ltd

The following data is part of a premarket notification filed by Innovita (tangshan) Biological Technology Co., Ltd with the FDA for Innovita Hcg Pregnancy Rapid Test Strip, Innovita Hcg Pregnancy Rapid Test Cassette, Innovita Hcg Pregnancy Rapid Test Midstream.

Pre-market Notification Details

Device IDK192843
501k NumberK192843
Device Name:INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant Innovita (Tangshan) Biological Technology Co., Ltd No. 699 Juxin Street, High-tech Industrial Development Zone Qian'an,  CN 064400
ContactLeo Lee
CorrespondentFiona Wang
Huajian US Services 19800 MacArthur Blvd, Ste 420 Irvine,  CA  92612
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
501k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-03
Decision Date2019-11-22

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