Data / Medical devices / United States / Inanovate Inc
Inanovate Inc: FDA-registered device maker in Sioux Falls, SD, United States, 1 510(k) clearance
Inanovate Inc is registered with the FDA (registration 3042641161) in Sioux Falls, SD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042641161
- Address
- 4800 N Career Ave Ste 132, Sioux Falls, SD, United States, 57107
- Owner or operator
- Inanovate Inc (10094564)
- Roles
- Manufacturer
- First device listed
- December 8, 2025
- Registered through
- 2027
- Brand names listed
- Bio-ID800, Lyme-ID IgG Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 14, 2025 | K252627 | Lyme-ID IgG Test; Bio-ID800 | LSR | Substantially Equivalent | Inanovate, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagent, Borrelia Serological Reagent
- All makers of Instrumentation For Clinical Multiplex Test Systems
Updated November 14, 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.