The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Plex Ena Profile 4.
| Device ID | K011140 |
| 510k Number | K011140 |
| Device Name: | QUANTA PLEX ENA PROFILE 4 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-07-27 |