Diastat Anti-Glomerular Basement Membrane Kit
FDA 510(k) K963525 · Shield Diagnostics, Ltd.
510(k) numberK963525
Submission
- Device name
- Diastat Anti-Glomerular Basement Membrane Kit
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- September 4, 1996
- Decision date
- November 7, 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
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| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL · Traditional | Immuno Concepts, N.A. , Ltd. | 10/19/2018SE |
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| 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 |
| 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 |
|---|---|---|
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200GGP · Traditional | 04/17/2000SE |
| K982879 | Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) AssayMSV · Traditional | 10/15/1998SE |
| K980885 | Shield Activated Factor Xii (Elisa) AssayGGP · Traditional | 08/21/1998SE |
| K972981 | Shield HELICO-G2 Elisa KitLYR · Traditional | 03/17/1998SE |
| K962825 | Shield Von Willebrand Factor Activity (Elisa) AssayGGP · Traditional | 11/15/1996SE |
| K961515 | Quantase Phenylalanine AssayJNB · Traditional | 06/12/1996SE |
| K955303 | Diastat Anti-Cardiolipin KitMID · Traditional | 05/30/1996SE |
| K952183 | Diastat Anti-Thyroglobulin KitJZO · Traditional | 06/30/1995SE |
| K951487 | Diastat Anti-Thyroid Peroxidase KitJZO · Traditional | 06/30/1995SE |
| K943630 | Diastat Anti-Mpo (Panca) KitMOB · Traditional | 03/06/1995SE |
Questions and answers
When was Diastat Anti-Glomerular Basement Membrane Kit cleared by the FDA?
Diastat Anti-Glomerular Basement Membrane Kit (K963525) received a 510(k) decision of Substantially Equivalent on November 7, 1996, 64 days after the submission was received.
What is the product code of K963525?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.