K000535 is an FDA 510(k) clearance for the QUANTA LITE LKM-1 ELISA. This device is classified as a Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) (Class II - Special Controls, product code NBS).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 7, 2000, 111 days after receiving the submission on February 17, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K000535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2000 |
| Decision Date | June 07, 2000 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NBS — Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |