510(k) K040854
K040854 is an FDA 510(k) premarket notification submitted by Focus Technologies, Inc. for the device "WEST NILE VIRUS IGM CAPTURE ELISA". The FDA issued a decision of Substantially Equivalent on June 30, 2004. 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
- June 30, 2004
- Date Received
- April 1, 2004
- 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.