K120439 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGG AND SYPHILIS IGG. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on March 14, 2012, 30 days after receiving the submission on February 13, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K120439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2012 |
| Decision Date | March 14, 2012 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |