The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Ena 5 Elisa Kit.
| Device ID | K943076 |
| 510k Number | K943076 |
| Device Name: | QUANTA LITE ENA 5 ELISA KIT |
| 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 | 1994-06-28 |
| Decision Date | 1994-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950544227 | K943076 | 000 |