Data / Medical devices / United States / Pharmajet, Inc.
Pharmajet, Inc.: FDA-registered device maker in Golden, CO, United States, 1 510(k) clearance
Pharmajet, Inc. is registered with the FDA (registration 3004977013) in Golden, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 27, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004977013
- Address
- 400 Corporate Cir Ste N, Golden, CO, United States, 80401
- Owner or operator
- PHARMAJET, INC. (9063237)
- Roles
- Manufacturer for export, Specification developer
- First device listed
- April 2, 2015
- Registered through
- 2026
- Brand names listed
- PharmaJet Stratis Needle-free Injection System, PharmaJet Tropis 0.1ml Needle Free Injection System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector, Fluid, Non-Electrically Powered | KZE | 2 | Manufacturer for export, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 27, 2011 | K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | KZE | Substantially Equivalent | Pharmajet, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 27, 2011. 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.