510(k) K021482
K021482 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA". The FDA issued a decision of Substantially Equivalent on July 30, 2002. The device falls under product code NIY (Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2002
- Date Received
- May 8, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis