CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
FDA 510(k) clearance K200370 · decided 2020-03-10
Clearance details
- K-number
- K200370
- Device name
- CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2020-02-14
- Decision date
- 2020-03-10
- Days to decision
- 25 days
- Clearance type
- Special
- 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
| Record | Firm | Date |
|---|---|---|
| CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 recall (Z-2220-2024) | Centers For Disease Control and Prevention | 2024-06-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |