K163538 is an FDA 510(k) clearance for the QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls. 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 September 6, 2017, 264 days after receiving the submission on December 16, 2016.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K163538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2016 |
| Decision Date | September 06, 2017 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NBS — Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |