The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Centromere (cenp-a & Cenp-b) Elisa.
| Device ID | K003959 |
| 510k Number | K003959 |
| Device Name: | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 -1234 |
| Contact | Bry C Myers |
| Correspondent | Bry C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 -1234 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-01-22 |