K073390 is an FDA 510(k) clearance for the DIASORIN LIASON RUBELLA IGG ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 21, 2008, 354 days after receiving the submission on December 3, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K073390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2007 |
| Decision Date | November 21, 2008 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |