COPALIS EBV-M ANTIBODY ASSAY
FDA 510(k) clearance K991459 · decided 1999-05-14
Clearance details
- K-number
- K991459
- Device name
- COPALIS EBV-M ANTIBODY ASSAY
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-26
- Decision date
- 1999-05-14
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- LJN
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOPLEX 2200 EBV IGM KIT (K123021) | Bio-Rad Laboratories | 2012-11-02 |
| PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381) | Focus Diagnostics, Inc. | 2008-08-04 |
| ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (K042092) | Zeus Scientific, Inc. | 2005-04-12 |
| MODIFICATION TO SERAQUEST VCA IGM (K033780) | Quest Intl., Inc. | 2004-01-15 |
| SERAQUEST EB VAC IGM (K990977) | Quest Intl., Inc. | 1999-10-06 |
| IMMUNOWELL VCA IGM TEST (K973939) | Genbio | 1998-08-10 |
| EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (K931520) | Mrl Diagnostics | 1994-04-26 |
| ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (K930020) | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331) | Baxter Diagnostics, Inc. | 1992-09-02 |
| EBV-VCA IGM ELISA (K915348) | Pharmacia Diagnostics, Inc. | 1992-02-14 |
| AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362) | Amico Laboratories, Inc. | 1991-10-07 |
| EBV IGM ELISA TEST (K910042) | Gull Laboratories, Inc. | 1991-02-21 |
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 |