K003959 is an FDA 510(k) clearance for the QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 22, 2001, 32 days after receiving the submission on December 21, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K003959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2000 |
| Decision Date | January 22, 2001 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |