Innovita HCG Pregnancy Rapid Combo Test— 510(k) K241919

Clearance details

Applicant

Innovita (Tangshan) Biological Technology Co., Ltd.

Product code

Code JHI

Device class

Class 2

Regulation

21 CFR 862.1155

Advisory panel

Clinical Chemistry

Date received

2024-07-01

Decision date

2024-08-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Qian'An, CN

• K203272 — Alltest Pregnancy Rapid Combo Test Cassette2022-01-31
• K172322 — Atellica IM Total hCG (ThCG)2018-03-29
• K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)2017-12-22
• K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip2016-02-24
• K130456 — WUNDER PREGNANCY TEST2014-04-08

• K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
• K192843 — INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream2019-11-22

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 →