The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Gp210 Elisa.
| Device ID | K040885 |
| 510k Number | K040885 |
| Device Name: | QUANTA LITE GP210 ELISA |
| Classification | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Gary L Norman |
| Correspondent | Gary L Norman INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | NRI |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-06-25 |