The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Omp Plus Elisa.
| Device ID | K081248 |
| 510k Number | K081248 |
| Device Name: | QUANTA LITE OMP PLUS ELISA |
| Classification | Antibodies, Outer-membrane Proteins |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Zakera Shums |
| Correspondent | Zakera Shums INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | OKM |
| CFR Regulation Number | 866.5785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2008-10-27 |