Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit
FDA 510(k) K001352 · Corgenix, Inc.
510(k) numberK001352
Submission
- Device name
- Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit
- Applicant
- Corgenix, Inc.
Westminster, CO, US - Received
- April 28, 2000
- Decision date
- April 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHC – System, Test, Systemic Lupus Erythematosus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5820
- Specialty
- Immunology
Other 510(k)s with product code DHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001398 | Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | Corgenix, Inc. | 03/30/2001SE |
| K930421 | Elias Dsdna AbsDHC · Traditional | Elias U.S.A., Inc. | 03/10/1993SE |
| K930247 | Human A-Ds DNA Eia Kit for Diagnostic UseDHC · Traditional | The Binding Site, Ltd. | 03/10/1993SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | General Biometrics, Inc. | 12/09/1991SE |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | Lipogen, Inc. | 01/24/1989SE |
| K872910 | Immuno/SleDHC · Traditional | Immunostics Co., Inc. | 08/12/1987SE |
| K821385 | Sero/Tex Le TestDHC · Traditional | Texas Immunology, Inc. | 05/28/1982SE |
| K810981 | Anti Ndna Immunoflourescent Test SysDHC · Traditional | Immuno-Products Industries | 04/29/1981SE |
| K810226 | Sle Anti-N-Dna Latex TestDHC · Traditional | Icl Scientific | 02/09/1981SE |
| K800992 | Cordia NPDHC · Traditional | Cordis Corp. | 05/08/1980SE |
More from Cordis Corp.
| 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 Igg Anti-Prothrombin Semi-Quantitative Test Kit cleared by the FDA?
Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit (K001352) received a 510(k) decision of Substantially Equivalent on April 9, 2001, 346 days after the submission was received.
What is the product code of K001352?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.