MDx-Chex for BCP— 510(k) K260041
Substantially EquivalentStreck, LLC
FDA 510(k) clearance K260041 for MDx-Chex for BCP, Substantially Equivalent on 2026-03-27. Applicant: Streck, LLC. Device class: 2.
Summary
Streck's MDx-Chex for BCP is filed under PMN, assayed external control material for microbiology nucleic acid amplification (NAT) assays. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 866.3920. It was a Traditional 510(k), and Microbiology is both the classification panel and the review panel.
Streck filed from La Vista, Nebraska. The decision came 80 calendar days after FDA received it (January 6 to March 27, 2026).
Clearance details
- Applicant
- Streck, LLC
- Product code
- Product code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Vista, NE, US
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