510(k) K031953
K031953 is an FDA 510(k) premarket notification submitted by Focus Technologies, Inc. for the device "WEST NILE VIRUS ELISA IGG, MODEL EL0300G". The FDA issued a decision of Substantially Equivalent on October 22, 2003. The device falls under product code NOP (Elisa, Antibody, West Nile Virus), a Class II device regulated under 21 CFR 866.3940. Focus Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2003
- Date Received
- June 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elisa, Antibody, West Nile Virus
- Device Class
- Class II
- Regulation Number
- 866.3940
- Review Panel
- MI
- Submission Type
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.