K153308 is an FDA 510(k) clearance for the EUROIMMUN Anti-West Nile Virus ELISA (IgM). This device is classified as a Elisa, Antibody, West Nile Virus (Class II - Special Controls, product code NOP).
Submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on August 12, 2016, 269 days after receiving the submission on November 17, 2015.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3940. The West Nile Virus Elisa Is Intended For The Detection Of Igg And Igm Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients..
| 510(k) Number | K153308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2015 |
| Decision Date | August 12, 2016 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NOP - Elisa, Antibody, West Nile Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3940 |
| Definition | The West Nile Virus Elisa Is Intended For The Detection Of Igg And Igm Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients. |