WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
FDA 510(k) clearance K041231 · decided 2004-08-10
Clearance details
- K-number
- K041231
- Device name
- WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
- Applicant
- Panbio Limited
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-08-10
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- NOP
- Device class
- 2
- Regulation number
- 866.3940
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Windsor, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the recall (Z-1014-2012) | Inverness Medical | 2012-02-14 |