EUROIMMUN Anti-West Nile Virus ELISA (IgG)
FDA 510(k) clearance K153303 · decided 2016-08-10
Clearance details
- K-number
- K153303
- Device name
- EUROIMMUN Anti-West Nile Virus ELISA (IgG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-16
- Decision date
- 2016-08-10
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NOP
- Device class
- 2
- Regulation number
- 866.3940
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Euroimmun Us
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) | Euroimmun Us, Inc. | 2016-08-12 |
| SPECTRAL WEST NILE VIRUS IGM STATUS TEST (K052519) | Spectral Diagnostics, Inc. | 2006-11-30 |
| WEST NILE DETECT IGM ELISA (K041817) | Inbios Intl., Inc. | 2004-11-19 |
| WEST NILE VIRUS IGG INDIRECT ELISA (K041068) | Panbio Limited | 2004-10-20 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (K041231) | Panbio Limited | 2004-08-10 |
| WEST NILE VIRUS IGM CAPTURE ELISA (K040854) | Focus Technologies, Inc. | 2004-06-30 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952) | Focus Technologies, Inc. | 2003-10-22 |
| WEST NILE VIRUS ELISA IGG, MODEL EL0300G (K031953) | Focus Technologies, Inc. | 2003-10-22 |
| WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004) | Panbio Limited | 2003-07-08 |
Recalls involving this device
No recalls on record reference this clearance.