Qaca Igg/Igm Elisa Kit
FDA 510(k) K020241 · Cheshire Diagnostics , Ltd.
510(k) numberK020241
Submission
- Device name
- Qaca Igg/Igm Elisa Kit
- Applicant
- Cheshire Diagnostics , Ltd.
Cheshire, GB - Received
- January 23, 2002
- Decision date
- March 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K021611 | QAB2A Igg Elisa Kit HRPMSV · Traditional | 07/12/2002SE |
| K021610 | QAB2A Igm Elisa Kit HRPMSV · Traditional | 07/12/2002SE |
| K021192 | Qaca Igg/Igm Elisa Kit HRPMID · Traditional | 05/16/2002SE |
| K020695 | QAB2A Igg Elisa KitMSV · Traditional | 04/19/2002SE |
| K020694 | QAB2A Igm Elisa KitMVS · Traditional | 04/19/2002SE |
Questions and answers
When was Qaca Igg/Igm Elisa Kit cleared by the FDA?
Qaca Igg/Igm Elisa Kit (K020241) received a 510(k) decision of Substantially Equivalent on March 13, 2002, 49 days after the submission was received.
What is the product code of K020241?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.