Quanta Lite PBC Screen Igg/Iga Elisa
FDA 510(k) K061842 · Inova Diagnostics, Inc.
510(k) numberK061842
Submission
- Device name
- Quanta Lite PBC Screen Igg/Iga Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- June 29, 2006
- Decision date
- October 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K040885 | Quanta Lite GP210 ElisaNRI · Traditional | Inova Diagnostics, Inc. | 06/25/2004SE |
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Questions and answers
When was Quanta Lite PBC Screen Igg/Iga Elisa cleared by the FDA?
Quanta Lite PBC Screen Igg/Iga Elisa (K061842) received a 510(k) decision of Substantially Equivalent on October 18, 2006, 111 days after the submission was received.
What is the product code of K061842?
The FDA product code is NRI – Autoantibodies, Nuclear Pore Glycoprotein Gp210, a Class II (moderate risk) device regulated under 21 CFR 866.5090.