Data / Medical devices / United States / Jay Group
Jay Group: FDA-registered device maker in Reno, NV, United States, 2 510(k) clearances
Jay Group is registered with the FDA (registration 3017125176) in Reno, NV, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017125176
- Address
- 1381 Capital Blvd Suite 200, Reno, NV, United States, 89502
- Owner or operator
- The Jay Group (10021837)
- Roles
- Repackager or relabeler
- First device listed
- August 11, 2022
- Registered through
- 2026
- Brand names listed
- MOSIE LLC, Sequel, TPC Inc. DBA August
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Human Chorionic Gonadotropin | DHA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 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 |
|---|---|---|---|---|---|---|
| August 3, 2023 | K230419 | Sequel Tampon with Plastic Applicator | HEB | Substantially Equivalent | Tampro, Inc. | accessdata.fda.gov |
| December 19, 1997 | K973825 | MIDSTREAM HOME REGNANCY TEST | DHA | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of System, Test, Human Chorionic Gonadotropin
Updated August 3, 2023. 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.