Quanta Lite GP210 Elisa
FDA 510(k) K040885 · Inova Diagnostics, Inc.
510(k) numberK040885
Submission
- Device name
- Quanta Lite GP210 Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- April 5, 2004
- Decision date
- June 25, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NRI – Autoantibodies, Nuclear Pore Glycoprotein Gp210
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.
Other 510(k)s with product code NRI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061842 | Quanta Lite PBC Screen Igg/Iga ElisaNRI · Traditional | Inova Diagnostics, Inc. | 10/18/2006SE |
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Questions and answers
When was Quanta Lite GP210 Elisa cleared by the FDA?
Quanta Lite GP210 Elisa (K040885) received a 510(k) decision of Substantially Equivalent on June 25, 2004, 81 days after the submission was received.
What is the product code of K040885?
The FDA product code is NRI – Autoantibodies, Nuclear Pore Glycoprotein Gp210, a Class II (moderate risk) device regulated under 21 CFR 866.5090.