The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Ro52, Quanta Flash Ro52 Calibrators, And Quanta Flash Ro52 Controls.
| Device ID | K141655 |
| 510k Number | K141655 |
| Device Name: | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS |
| Classification | Anti-ss-a 52 Autoantibodies |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Grabriella Lakos |
| Correspondent | Grabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | OBE |
| 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 | 2014-06-20 |
| Decision Date | 2015-03-05 |
| Summary: | summary |