Reaads Iga ANTI-B2GP 1 Test Kit
FDA 510(k) K982434 · Corgenix, Inc.
510(k) numberK982434
Submission
- Device name
- Reaads Iga ANTI-B2GP 1 Test Kit
- Applicant
- Corgenix, Inc.
Westminster, CO, US - Received
- July 14, 1998
- Decision date
- December 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | Immco Diagnostics, Inc. | 06/19/2017SE |
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| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar ANTI-¿2GPI DOMAIN1; Controls.MSV · Traditional | Inova Diagnostics, Inc. | 02/13/2015SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | Phadia US, Inc. | 06/22/2012SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | Instrumentation Laboratory CO | 05/21/2010SE |
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
More from Aesku, 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-B2GP 1 Test Kit cleared by the FDA?
Reaads Iga ANTI-B2GP 1 Test Kit (K982434) received a 510(k) decision of Substantially Equivalent on December 22, 1998, 161 days after the submission was received.
What is the product code of K982434?
The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.