CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
FDA 510(k) clearance K243931 · decided 2025-03-14
Clearance details
- K-number
- K243931
- Device name
- CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2024-12-20
- Decision date
- 2025-03-14
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OZE
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |