FDA.report

510(k) K254167

Device
MDx-Chex for BCY
Applicant
Streck, LLC
510(k) number
K254167
Product code
PMN
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-17
Date received
2025-12-23
Regulation
866.3920
Classification name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Megan Hiveley
Address
7002 S 109th St. La Vista NE US 68128 68128

FDA Registration Numbers

Source Documents

510(k) summary PDF

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