K062211 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on December 8, 2006, 129 days after receiving the submission on August 1, 2006.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K062211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2006 |
| Decision Date | December 08, 2006 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| 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 |