Data / Medical devices / United States / Instanosis Inc.
Instanosis Inc.: FDA-registered device maker in King of Prussia, PA, United States, 1 510(k) clearance
Instanosis Inc. is registered with the FDA (registration 3030897502) in King of Prussia, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 28, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030897502
- Address
- 1004 W 9th Avenue, Suite 10, King of Prussia, PA, United States, 19406
- Owner or operator
- Instanosis Inc. (10090518)
- Roles
- Manufacturer
- First device listed
- April 8, 2024
- Registered through
- 2027
- Brand names listed
- InstaStrip Fentanyl Dipstick Test (Urine), InstaStrip Fentanyl Rapid Test (Urine)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Opiates, Over The Counter | NGL | 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 |
|---|---|---|---|---|---|---|
| March 28, 2024 | K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | NGL | Substantially Equivalent | Instanosis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 28, 2024. 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.