510(k) K062213
- Device
- BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- Applicant
- BIO-RAD LABORATORIES, INC.
- 510(k) number
- K062213
- Product code
- LSE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-08
- Date received
- 2006-08-01
- Regulation
- 866.3235
- Classification name
- Epstein-barr Virus, Other
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID BHEND
- Address
- 6565 185th Ave., NE Redmond WA US 98052 98052
FDA Registration Numbers#
- 2918768
- 3002800697
- 9610240
- 3007208259
- 3004140393
- 1318354
- 3032705
- 9610746
- 2242436
- 2029372
- 2245285
- 1641328
- 3022178699
- 2090110
- 2915274
Source Documents#
Other 510(k) Records For Product Code LSE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | 2024-08-07 |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | DiaSorin, Inc. | 2017-01-05 |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. | 2017-01-04 |
| K091260 | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | 2009-06-08 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | 2008-07-28 |
| K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| K060204 | LIAISON EA IGG | DiaSorin, Inc. | 2006-10-18 |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | 2004-01-16 |
| K030863 | EBV VCA-P18 IGG ELISA | Panbio Limited | 2003-06-27 |
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-09-27 |
| K010301 | IMMUNOWELL EA (D) IGG TEST | Genbio | 2001-06-11 |
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Stellar Bio Systems, Inc. | 1999-12-22 |
| K991975 | SERAQUEST EB NA IGG | Quest Intl., Inc. | 1999-11-02 |
| K990410 | SERAQUEST EB VCA IGG | Quest Intl., Inc. | 1999-10-28 |
| K992191 | ETI-EA-G ASSAY | DiaSorin, Inc. | 1999-07-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary