HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

Kit, Test, Pregnancy, Hcg, Over The Counter

Qingdao Hightop Biotech Co., Ltd.

The following data is part of a premarket notification filed by Qingdao Hightop Biotech Co., Ltd. with the FDA for Hightop Pregnancy Rapid Test Cassette, Hightop Pregnancy Rapid Test Strip, Hightop Pregnancy Rapid Test Midstream.

Pre-market Notification Details

Device IDK192123
510k NumberK192123
Device Name:HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant Qingdao Hightop Biotech Co., Ltd. No. 369 Hedong Road, Hi-tech Industrial Development Zone Qingdao,  CN 266112
ContactAllen Lee
CorrespondentJoe Shia
LSI International 504 E. Diamond Ave., Suite I Gaithersburg,  MD  20877
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2019-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16935091670003 K192123 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.