Data / Medical devices / United States / Tetracore, Inc
Tetracore, Inc: FDA-registered device maker in Potomac, MD, United States, 1 510(k) clearance
Tetracore, Inc is registered with the FDA (registration 3003517954) in Potomac, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2003. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003517954
- Address
- 77 Upper Rock Circle SUITE 600, Potomac, MD, United States, 20850
- Owner or operator
- TETRACORE, INC (9060889)
- Roles
- Manufacturer
- First device listed
- January 30, 2004
- Registered through
- 2026
- Brand names listed
- EZ-SARS-CoV-2 Real-Time RT-PCR, REDLINE ALERT TEST
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody | NPO | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | N | 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 |
|---|---|---|---|---|---|---|
| December 9, 2003 | K030370 | REDLINE ANTHRAX ALERT TEST | NPO | Substantially Equivalent | Tetracore, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 9, 2003. 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.