Diastat Anti-Mitochondrial Antibody Kit
FDA 510(k) K921183 · Shield Diagnostics, Ltd.
510(k) numberK921183
Submission
- Device name
- Diastat Anti-Mitochondrial Antibody Kit
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- March 9, 1992
- Decision date
- June 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
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| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | The Binding Site, Ltd. | 03/24/2003SE |
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| K971909 | Virgo Ama Elisa KitDBM · Traditional | Hemagen Diagnostics, Inc. | 06/20/1997SE |
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| 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-Mitochondrial Antibody Kit cleared by the FDA?
Diastat Anti-Mitochondrial Antibody Kit (K921183) received a 510(k) decision of Substantially Equivalent on June 19, 1992, 102 days after the submission was received.
What is the product code of K921183?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.