The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Ena7.
| Device ID | K122923 |
| 510k Number | K122923 |
| Device Name: | QUANTA FLASH ENA7 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Michael Mahler |
| Correspondent | Michael Mahler INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | LLL |
| 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 | 2012-09-24 |
| Decision Date | 2013-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950627821 | K122923 | 000 |
| 08426950566397 | K122923 | 000 |
| 08426950566380 | K122923 | 000 |
| 08426950566373 | K122923 | 000 |