Igg Anti-Atherox Test Kit
FDA 510(k) K072032 · Corgenix, Inc.
510(k) numberK072032
Submission
- Device name
- Igg Anti-Atherox Test Kit
- Applicant
- Corgenix, Inc.
Broomfield, CO, US - Received
- July 24, 2007
- Decision date
- April 4, 2008
- 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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| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
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| 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 |
| K022990 | Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001MID · Special | 09/25/2002SE |
Questions and answers
When was Igg Anti-Atherox Test Kit cleared by the FDA?
Igg Anti-Atherox Test Kit (K072032) received a 510(k) decision of Substantially Equivalent on April 4, 2008, 255 days after the submission was received.
What is the product code of K072032?
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.