INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.
Qian'an Hebei, CN
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. appears in FDA device records in Qian'an Hebei, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. between 2019 and 2025. The busiest year on record is 2019, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250398 | Innovita Flu A/B Antigen Rapid Test | PSZ | Substantially Equivalent | |
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | JHI | Substantially Equivalent | |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013332582 | 3013332582 | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | No.699 Juxin Street,High-tech Industrial Development Zone, Qian'an Hebei 064400 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain