The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Ena Elisa.
| Device ID | K922829 |
| 510k Number | K922829 |
| Device Name: | QUANTA LITE ENA ELISA |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1992-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950454496 | K922829 | 000 |