Medical Device Manufacturer · US , La Vista , NE

Streck, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2026

Total

Cleared

Denied

Streck, LLC develops quality control products, sample stabilization solutions, and laboratory diagnostic tools. Founded in 1971, the company is headquartered in La Vista, Nebraska, and operates with a mission to ensure every laboratory test result is trusted and reliable.

Streck has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Microbiology devices. The company's first clearance was in 2026, with the latest clearance also in 2026, demonstrating active regulatory engagement in this category.

The company specializes in Microbiology quality control and verification products, including blood culture testing solutions. Streck also manufactures sample stabilization products such as blood collection tubes and preservation reagents designed to maintain sample integrity from collection through analysis.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to learn more about Streck's cleared submissions.

FDA 510(k) Regulatory Record - Streck, LLC

2 devices

1-2 of 2