Eia Kit for the Detection of GBM Antibodies
FDA 510(k) K953495 · Scimedx Corp.
510(k) numberK953495
Submission
- Device name
- Eia Kit for the Detection of GBM Antibodies
- Applicant
- Scimedx Corp.
Denvill, NJ, US - Received
- July 26, 1995
- Decision date
- April 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code DBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL · Traditional | Immuno Concepts, N.A. , Ltd. | 10/19/2018SE |
| K980312 | Nova Lite EndomysialDBL · Traditional | Inova Diagnostics, Inc. | 04/02/1998SE |
| K974169 | Wielisa Anti-Gbm Test SystemDBL · Traditional | Wieslab AB | 02/17/1998SE |
| K971464 | Immunoscan Anti-Gbm Quantitative KitDBL · Traditional | Euro-Diagnostica AB | 10/29/1997SE |
| K971658 | Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional | Jay H. Geller | 05/23/1997SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | Shield Diagnostics, Ltd. | 11/07/1996SE |
| K955431 | Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional | The Binding Site, Ltd. | 04/23/1996SE |
| K944192 | Anti-Nuclear Antibody (Ana) Test Kit W/Rat LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K913360 | Anti-Reticulin Antibody (Ara) TestDBL · Traditional | Immco Diagnostics, Inc. | 09/26/1994SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011348 | Phase II GBM Igg Antibody Eia TestMVJ · Traditional | 06/25/2001SE |
| 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 |
Questions and answers
When was Eia Kit for the Detection of GBM Antibodies cleared by the FDA?
Eia Kit for the Detection of GBM Antibodies (K953495) received a 510(k) decision of Substantially Equivalent on April 10, 1996, 259 days after the submission was received.
What is the product code of K953495?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.