510(k) clearance
B. anthracis Real-time PCR Assay
- 510(k) number
- K262368
- Applicant
- Centers for Disease Control and Prevention
- Decision date
- Oct 7, 2026
- Date received
- Jul 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NHT
- Device type
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device class
- Class II
- Regulation
- 21 CFR 866.3045
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Atlanta, GA, US