K040120 is an FDA 510(k) clearance for the DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS. This device is classified as a Test, Antigen, Nuclear, Epstein-barr Virus (Class I - General Controls, product code LLM).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on April 29, 2005, 465 days after receiving the submission on January 20, 2004.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K040120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | April 29, 2005 |
| Days to Decision | 465 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LLM — Test, Antigen, Nuclear, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |