510(k) K041068
K041068 is an FDA 510(k) premarket notification submitted by Panbio Limited for the device "WEST NILE VIRUS IGG INDIRECT ELISA". The FDA issued a decision of Substantially Equivalent on October 20, 2004. The device falls under product code NOP (Elisa, Antibody, West Nile Virus), a Class II device regulated under 21 CFR 866.3940. Panbio Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2004
- Date Received
- April 26, 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.