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

Substantially Equivalent

Innovita (Tangshan) Biological Technology Co., Ltd.

FDA 510(k) clearance K241919 for Innovita HCG Pregnancy Rapid Combo Test, Substantially Equivalent on 2024-08-02. Applicant: Innovita (Tangshan) Biological Technology Co., Ltd..

Clearance details

Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2024-07-01
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qian'An, 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.