Data / Medical devices / United States / Quanovate Tech Inc.
Quanovate Tech Inc.: FDA-registered device maker in San Ramon, CA, United States, 1 510(k) clearance
Quanovate Tech Inc. is registered with the FDA (registration 3013501873) in San Ramon, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013501873
- Address
- 111 Deerwood Rd Ste 200, San Ramon, CA, United States, 94583
- Owner or operator
- Quanovate Tech Inc. (10054431)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 10, 2021
- Registered through
- 2026
- Brand names listed
- Mira Basal Body Thermometer, Mira Confirm Wand, Mira Max Wand, Mira Ovum Wand, Mira Plus Wand, Mira Pregnancy Test, Mira Ultra4 Wand
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Fertility Diagnostic, Proceptive | LHD | U | Specification developer | accessdata.fda.gov |
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 22, 2019 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | Substantially Equivalent | Runbio Biotech Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay, Pregnanediol Glucuronide, Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Device, Fertility Diagnostic, Proceptive
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated February 22, 2019. 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.