510(k) K061842
- Device
- QUANTA LITE PBC SCREEN IGG/IGA ELISA
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K061842
- Product code
- NRI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-18
- Date received
- 2006-06-29
- Regulation
- 866.5090
- Classification name
- Autoantibodies, Nuclear Pore Glycoprotein Gp210
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY L NORMAN
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2026994
- 3012348571
- 3007118747
- 3003268355
- 3007361513
Source Documents#
Other 510(k) Records For Product Code NRI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040885 | QUANTA LITE GP210 ELISA | Inova Diagnostics, Inc. | 2004-06-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary