Diastat Anti-Histone Kit
FDA 510(k) K920616 · Shield Diagnostics, Ltd.
510(k) numberK920616
Submission
- Device name
- Diastat Anti-Histone Kit
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- February 11, 1992
- Decision date
- July 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
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| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
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| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
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| 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 |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | 11/07/1996SE |
| 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 |
Questions and answers
When was Diastat Anti-Histone Kit cleared by the FDA?
Diastat Anti-Histone Kit (K920616) received a 510(k) decision of Substantially Equivalent on July 14, 1992, 154 days after the submission was received.
What is the product code of K920616?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.