Wielisa Anti-Gbm Test System
FDA 510(k) K974169 · Wieslab AB
510(k) numberK974169
Submission
- Device name
- Wielisa Anti-Gbm Test System
- Applicant
- Wieslab AB
Frederick, MD, US - Received
- November 5, 1997
- Decision date
- February 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K953495 | Eia Kit for the Detection of GBM AntibodiesDBL · Traditional | Scimedx Corp. | 04/10/1996SE |
| 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 |
|---|---|---|
| K981750 | Wielisa Anti-Gbm, Anca Screening Kit Test SystemMOB · Traditional | 07/22/1998SE |
| K981748 | Wielisa Anca Screening Kit Test SystemMOB · Traditional | 07/22/1998SE |
| K974167 | Wielisa PR-3 Anca Test SystemMOB · Traditional | 02/17/1998SE |
| K974166 | Wielisa Mpo Anca Test SystemMOB · Traditional | 02/17/1998SE |
Questions and answers
When was Wielisa Anti-Gbm Test System cleared by the FDA?
Wielisa Anti-Gbm Test System (K974169) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 104 days after the submission was received.
What is the product code of K974169?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.