Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) Assay
FDA 510(k) K982879 · Shield Diagnostics, Ltd.
510(k) numberK982879
Submission
- Device name
- Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) Assay
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- August 14, 1998
- Decision date
- October 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200GGP · Traditional | 04/17/2000SE |
| 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 |
| K943630 | Diastat Anti-Mpo (Panca) KitMOB · Traditional | 03/06/1995SE |
Questions and answers
When was Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) Assay cleared by the FDA?
Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) Assay (K982879) received a 510(k) decision of Substantially Equivalent on October 15, 1998, 62 days after the submission was received.
What is the product code of K982879?
The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.