Anti-Cardiolipin Antibody Test System
FDA 510(k) K911661 · Immuno Concepts, Inc.
510(k) numberK911661
Submission
- Device name
- Anti-Cardiolipin Antibody Test System
- Applicant
- Immuno Concepts, Inc.
Sacramento, CA, US - Received
- April 12, 1991
- Decision date
- December 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MID – System, Test, Anticardiolipin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | Inova Diagnostics, Inc. | 12/17/2024SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | Phadia US, Inc. | 12/23/2013SE |
| K130528 | Bioplex 2200 Apls IgmMID · Traditional | Bio-Rad Laboratories | 10/21/2013SE |
| K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaMID · Traditional | Inova Diagnostics, Inc. | 02/26/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | Immco Diagnostics, Inc. | 10/25/2012SE |
| K103834 | Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsMID · Traditional | Bio-Rad Laboratories | 03/30/2012SE |
| K102425 | Zeus Elisa Cardiolipin Igg/Igm/Iga Test SystemMID · Traditional | Zeus Scientific, Inc. | 12/12/2011SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | Phadia US, Inc. | 06/07/2010SE |
| K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsMID · Traditional | Instrumentation Laboratory CO | 03/11/2010SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | Theratest Laboratories, Inc. | 02/07/2006SE |
More from Theratest Laboratories, 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 Anti-Cardiolipin Antibody Test System cleared by the FDA?
Anti-Cardiolipin Antibody Test System (K911661) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 241 days after the submission was received.
What is the product code of K911661?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.