K031952 is an FDA 510(k) clearance for the WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M. This device is classified as a Elisa, Antibody, West Nile Virus (Class II - Special Controls, product code NOP).
Submitted by Focus Technologies, Inc. (Cypress, US). The FDA issued a Cleared decision on October 22, 2003, 119 days after receiving the submission on June 25, 2003.
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 | K031952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2003 |
| Decision Date | October 22, 2003 |
| Days to Decision | 119 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. |