Data / Medical devices / Hong Kong / Hian (hong Kong) Co., Limited
Hian (hong Kong) Co., Limited: FDA-registered device maker in Hong Kong, Hong Kong, 6 510(k) clearances
Hian (hong Kong) Co., Limited is registered with the FDA (registration 3028107593) in Hong Kong, Hong Kong. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3028107593
- Address
- Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong., Hong Kong, Hong Kong, 94085
- Owner or operator
- Hian (Hong Kong) Co., Limited (10088625)
- Roles
- Exporter to the US
- First device listed
- September 6, 2023
- Registered through
- 2027
- Brand names listed
- CVS COVID-19&Flu A/B&RSV Antigen Test (model: ICR-3000), Equate COVID-19 Test Kit Single, iHealth (KN-550BT), iHealth (model: PO3), iHealth COVID-19 Antigen Rapid Test (model: ICO-3000), iHealth COVID-19 Antigen Rapid Test (model:ICO-3000), iHealth COVID-19 Antigen Rapid Test Pro (model: ICO-3000P), iHealth COVID-19/Flu A&B Rapid Test and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Exporter to the US | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Exporter to the US | accessdata.fda.gov |
| Covid-19 Multi-Analyte Antigen Device | QMN | N | Exporter to the US | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Covid-19 Antigen Test | QYT | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2025 | K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | SCA | Substantially Equivalent | Ihealth Labs, Inc. | accessdata.fda.gov |
| December 12, 2025 | K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | SCA | Substantially Equivalent | Ihealth Labs, Inc. | accessdata.fda.gov |
| December 20, 2024 | K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | LCX | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| May 31, 2024 | K233842 | iHealth COVID-19 Antigen Rapid Test | QYT | Substantially Equivalent | Ihealth Labs, Inc. | accessdata.fda.gov |
| February 2, 2016 | K160014 | iHealth Track Blood Pressure Monitor | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| September 24, 2015 | K152003 | iHealth BP3L Wireless Blood Pressure Monitor | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Over-The-Counter Covid-19 Antigen Test
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Covid-19 Multi-Analyte Antigen Device
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated December 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.