Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip— 510(k) K152768

Substantially Equivalent

Assure Tech. Co., Ltd.

FDA 510(k) clearance K152768 for Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip, Substantially Equivalent on 2016-02-24. Applicant: Assure Tech. Co., Ltd..

Clearance details

Applicant: Assure Tech. Co., Ltd.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2015-09-24
Decision date: 2016-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.