Ebv-Vca Igm Antibody Test System (Fluorescent)
FDA 510(k) K880886 · Immuno Concepts, Inc.
510(k) numberK880886
Submission
- Device name
- Ebv-Vca Igm Antibody Test System (Fluorescent)
- Applicant
- Immuno Concepts, Inc.
Sacramento, CA, US - Received
- March 2, 1988
- Decision date
- August 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJN – Antibody Igm, If, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LJN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123021 | Bioplex 2200 Ebv Igm KitLJN · Traditional | Bio-Rad Laboratories | 11/02/2012SE |
| K073381 | Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600MLJN · Traditional | Focus Diagnostics, Inc. | 08/04/2008SE |
| K042092 | Athena Multi-Lyte Ebv Vca Igm Test SystemLJN · Traditional | Zeus Scientific, Inc. | 04/12/2005SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | Quest Intl., Inc. | 01/15/2004SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | Quest Intl., Inc. | 10/06/1999SE |
| K991459 | Copalis Ebv-M Antibody AssayLJN · Traditional | DiaSorin, Inc. | 05/14/1999SE |
| K973939 | Immunowell Vca Igm TestLJN · Traditional | Genbio | 08/10/1998SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | Mrl Diagnostics | 04/26/1994SE |
| K930020 | Ortho*Epstein-Barr Virus Vca-Igm Antibody ElisaLJN · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1993SE |
| K922331 | Bartels Epstein-Barr Virus Igm EiaLJN · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
More from Baxter Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional | 11/29/2001SE |
| K013285 | Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15MOB · Traditional | 11/14/2001SE |
| K013283 | Relisa PR3-ANCA Test System for Antibodies to Proteinase 3, Model # 7096-16MOB · Traditional | 11/14/2001SE |
| K992041 | Relisa Ana Screening Test System, Model 7096-11LJM · Traditional | 07/23/1999SE |
| K983924 | HEP-2000 Colorzyme Ana-Ro Test System, Model 4200-RODHN · Traditional | 12/18/1998SE |
| K972145 | HEP-2000 Fluorescent Ana-Ro Test SystemDHN · Traditional | 02/24/1998SE |
| K974478 | Immuno Concepts Anca Test SystemsMOB · Traditional | 02/09/1998SE |
| K974463 | Immuno Concepts Anca Test SystemMOB · Traditional | 02/09/1998SE |
| K963275 | Relisa Ena Single Well Screen Antibody Test SystemLLL · Traditional | 09/13/1996SE |
| K955605 | Relisa JO-1 Antibody Test SystemLLL · Traditional | 04/19/1996SE |
Questions and answers
When was Ebv-Vca Igm Antibody Test System (Fluorescent) cleared by the FDA?
Ebv-Vca Igm Antibody Test System (Fluorescent) (K880886) received a 510(k) decision of Substantially Equivalent on August 30, 1988, 181 days after the submission was received.
What is the product code of K880886?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.