K162959 is an FDA 510(k) clearance for the LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on January 4, 2017, 72 days after receiving the submission on October 24, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K162959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2016 |
| Decision Date | January 04, 2017 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |