Data / Medical devices / United States / Vivosens Inc
Vivosens Inc: FDA-registered device maker in San Francisco, CA, United States, 4 510(k) clearances
Vivosens Inc is registered with the FDA (registration 3018126397) in San Francisco, CA, United States. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018126397
- Address
- 44 Tehama Street, Suite 409, San Francisco, CA, United States, 94105
- Owner or operator
- Vivosens Inc (10085777)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 5, 2023
- Registered through
- 2026
- Brand names listed
- Vivoo, Vivoo FSH Fertility Test, Vivoo LH Ovulation Test, Vivoo Sediva Sedimentation Test, Vivoo Sediva Sedimentation Test Tube, Vivoo hCG Pregnancy Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Paper, Obstetric Ph | LNW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Refractometer For Clinical Use | JRE | 1 | Specification developer | accessdata.fda.gov |
| Test, Erythrocyte Sedimentation Rate | JPH | 1 | Specification developer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Sedimentation Rate | GHC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 30, 2025 | K252607 | AllTest Urinary Tract Infection Test | JMT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| April 12, 2024 | K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | LCX | Substantially Equivalent | Hangzhou Aichek Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | LCX | Substantially Equivalent | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Test, Urine Leukocyte
Updated October 30, 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.