Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test Kit
FDA 510(k) K000920 · Corgenix, Inc.
510(k) numberK000920
Submission
- Device name
- Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test Kit
- Applicant
- Corgenix, Inc.
Westminster, CO, US - Received
- March 22, 2000
- Decision date
- April 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | 04/04/2008SE |
| K062025 | Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136OBW · Traditional | 05/29/2007SE |
| K042680 | Rhigene Hep-Ana Test SystemDHN · Traditional | 11/19/2004SE |
| K032139 | Reaads Von Willebrand Factor Activity Test Kit, Model 10826GGP · Traditional | 04/05/2004SE |
| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | 01/08/2004SE |
| K032868 | Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139MID · Special | 10/14/2003SE |
| K031208 | Reaads Igm ANTI-B2GPI Test Kit, Model 038-001MSV · Special | 07/07/2003SE |
| K024196 | Reeads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test KitMID · Special | 01/03/2003SE |
| K024195 | Modification to Reaads Anti-Phosphatidylserine Iga Semi-Quantative Test KitMID · Special | 01/03/2003SE |
| K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001MID · Special | 09/25/2002SE |
Questions and answers
When was Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test Kit cleared by the FDA?
Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test Kit (K000920) received a 510(k) decision of Substantially Equivalent on April 26, 2000, 35 days after the submission was received.
What is the product code of K000920?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.