The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Centromere.
| Device ID | K123880 |
| 510k Number | K123880 |
| Device Name: | QUANTA FLASH CENTROMERE |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Andrea Seaman |
| Correspondent | Andrea Seaman INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | LJM |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2014-02-07 |