B. anthracis Real-time PCR Assay— 510(k) K262368
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K262368 for B. anthracis Real-time PCR Assay, Substantially Equivalent on 2026-10-07. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Summary
This B. anthracis Real-time PCR Assay is filed under NHT, nucleic acid amplification assays for Bacillus anthracis. The applicant is the Centers for Disease Control and Prevention.
Class II, 21 CFR 866.3045. The Microbiology panel reviewed it as a Traditional 510(k).
CDC filed from Atlanta, Georgia. Review took 89 days (July 10 to October 7, 2026).
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Product code NHT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3045
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
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