Data / Medical devices / United States / Assembly-Tek LLC
Assembly-Tek LLC: FDA-registered device maker in Dayton, OH, United States, 1 510(k) clearance
Assembly-Tek LLC is registered with the FDA (registration 3021119558) in Dayton, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021119558
- Address
- 295 S Alex Rd, Dayton, OH, United States, 45449
- Owner or operator
- Assembly-Tek / NCE (10083684)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- December 10, 2021
- Registered through
- 2026
- Brand names listed
- EZ-TRAX, OTK 210 One Tray Processing Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 13, 2006 | K052567 | ONE TRAY SEALED STERILIZATION CONTAINER | KCT | Substantially Equivalent | Sterile Containment Technology, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 13, 2006. 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.