Phase II GBM Igg Antibody Eia Test
FDA 510(k) K011348 · Scimedx Corp.
510(k) numberK011348
Submission
- Device name
- Phase II GBM Igg Antibody Eia Test
- Applicant
- Scimedx Corp.
Denvill, NJ, US - Received
- May 2, 2001
- Decision date
- June 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MVJ – Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MVJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071219 | Athena Multi-Lyte GBM Test SystemMVJ · Traditional | Zeus Scientific, Inc. | 12/06/2007SE |
| K072358 | Bioplex Vasculitis KitMVJ · Traditional | Bio-Rad Laboratories | 10/31/2007SE |
| K991890 | Autostat II Anti-Gbm Elisa, Hy.Tec Anti-Gmb ElisaMVJ · Traditional | Cogent Diagnotics , Ltd. | 08/09/1999SE |
| K984619 | Binding Site Bindazyme Anti-Gbm Eia Diagnostic Test KitMVJ · Traditional | The Binding Site, Ltd. | 02/23/1999SE |
| K984336 | Quanta Lite GBM ElisaMVJ · Traditional | Inova Diagnostics, Inc. | 02/08/1999SE |
More from Inova Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011082 | Tpo Igg Antibody Eia TestJZO · Traditional | 06/06/2001SE |
| K010625 | Eurospital Eu-Ttg Iga UmanaMVM · Traditional | 04/24/2001SE |
| K010287 | Scimedx Phase II PR3 Igg Antibody EiaMOB · Traditional | 03/16/2001SE |
| K010289 | Scimedx Phase II Mpo Igg Antibody EiaMOB · Traditional | 03/07/2001SE |
| K002189 | Gliadin Igg Antibody Eia Detection SystemMST · Traditional | 10/19/2000SE |
| K002169 | Gliadin Iga Antibody Eia Detection SystemMST · Traditional | 10/19/2000SE |
| K002107 | Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord…MVM · Traditional | 08/04/2000SE |
| K994379 | Eu-Ttg Iga ElisaMVM · Traditional | 02/18/2000SE |
| K970198 | Ifa HEP2 Kit for the Detection of Antinuclear AntibodiesDHN · Traditional | 02/20/1997SE |
| K962360 | Ifa Kit for the Detection of C-Anca AntibodiesMOB · Traditional | 09/30/1996SE |
Questions and answers
When was Phase II GBM Igg Antibody Eia Test cleared by the FDA?
Phase II GBM Igg Antibody Eia Test (K011348) received a 510(k) decision of Substantially Equivalent on June 25, 2001, 54 days after the submission was received.
What is the product code of K011348?
The FDA product code is MVJ – Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm), a Class II (moderate risk) device regulated under 21 CFR 866.5660.