The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Ro60, Quanta Flash Ro60 Calibrators, Quanta Flash Ro60 Controls.
| Device ID | K141328 |
| 510k Number | K141328 |
| Device Name: | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 -1638 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 -1638 |
| Product Code | LLL |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2015-02-12 |
| Summary: | summary |