INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
FDA 510(k) clearance K140851 · decided 2014-04-25
Clearance details
- K-number
- K140851
- Device name
- INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2014-04-03
- Decision date
- 2014-04-25
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- OEP
- 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 |