The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Dsdna, Quanta Flash Dsdna Calibrators And Quanta Flash Dsdna Controls.
| Device ID | K152013 |
| 510k Number | K152013 |
| Device Name: | QUANTA Flash DsDNA, QUANTA Flash DsDNA Calibrators And QUANTA Flash DsDNA Controls |
| Classification | Anti-dna Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Product Code | LSW |
| 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 | 2015-07-21 |
| Decision Date | 2016-04-11 |
| Summary: | summary |