Colorzyme Ebv Early Antigen Igg Antibody Test Sys
FDA 510(k) K912489 · Immuno Concepts, Inc.
510(k) numberK912489
Submission
- Device name
- Colorzyme Ebv Early Antigen Igg Antibody Test Sys
- Applicant
- Immuno Concepts, Inc.
Sacramento, CA, US - Received
- June 4, 1991
- Decision date
- July 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
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| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
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| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
More from Panbio Limited
| 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 Colorzyme Ebv Early Antigen Igg Antibody Test Sys cleared by the FDA?
Colorzyme Ebv Early Antigen Igg Antibody Test Sys (K912489) received a 510(k) decision of Substantially Equivalent on July 24, 1991, 50 days after the submission was received.
What is the product code of K912489?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.