Data / Medical devices / United States / Streck LLC
Streck LLC: FDA-registered device maker in La Vista, NE, United States, 2 510(k) clearances
Streck LLC is registered with the FDA (registration 3017953151) in La Vista, NE, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 7, 2020. 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
- 3017953151
- Address
- 11710 Peel Circle --, La Vista, NE, United States, 68128
- Owner or operator
- STRECK (1950302)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 21, 2013
- Registered through
- 2026
- Brand names listed
- Cell-Free DNA BCT, Cyto-Chex BCT, Guardant cfDNA BCT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Collection Device For Cell-Free Nucleic Acid | QMA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 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 |
|---|---|---|---|---|---|---|
| August 7, 2020 | DEN200001 | Cell-Free DNA BCT | QMA | Unknown | Streck, Inc. | accessdata.fda.gov |
| July 31, 2008 | K080552 | CYTO-CHEX BCT | GIM | Substantially Equivalent | Streck | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vacuum Sample, With Anticoagulant
- All makers of Blood Collection Device For Cell-Free Nucleic Acid
Updated August 7, 2020. 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.