LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
FDA 510(k) clearance K162961 · decided 2017-01-05
Clearance details
- K-number
- K162961
- Device name
- LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-24
- Decision date
- 2017-01-05
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- LSE
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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| BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213) | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| LIAISON EA IGG (K060204) | DiaSorin, Inc. | 2006-10-18 |
| MODIFICATION TO SERAQUEST EB VCA IGG (K033915) | Quest Intl., Inc. | 2004-01-16 |
| EBV VCA-P18 IGG ELISA (K030863) | Panbio Limited | 2003-06-27 |
| EBV EA-D IGG ELISA KIT, MODEL EBG-100 (K021793) | Pan Bio Pty. , Ltd. | 2002-09-27 |
| IMMUNOWELL EA (D) IGG TEST (K010301) | Genbio | 2001-06-11 |
| EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587) | Stellar Bio Systems, Inc. | 1999-12-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |