Assure Tech HCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech HCG Pregnancy Serum/Urine Combo Test Strip

Visual, Pregnancy Hcg, Prescription Use

ASSURE TECH. CO., LTD.

The following data is part of a premarket notification filed by Assure Tech. Co., Ltd. with the FDA for Assure Tech Hcg Pregnancy Serum/urine Combo Test Cassette, Assure Tech Hcg Pregnancy Serum/urine Combo Test Strip.

Pre-market Notification Details

Device IDK152768
510k NumberK152768
Device Name:Assure Tech HCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech HCG Pregnancy Serum/Urine Combo Test Strip
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant ASSURE TECH. CO., LTD. 2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD, Hangzhou,  CN 310030
ContactEric Lin
CorrespondentJoe Shia
LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg,  MD  20877
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-24
Decision Date2016-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06952804801830 K152768 000
06952804801212 K152768 000
06952804801205 K152768 000
06952804801090 K152768 000

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