Shield Von Willebrand Factor Activity (Elisa) Assay
FDA 510(k) K962825 · Shield Diagnostics, Ltd.
510(k) numberK962825
Submission
- Device name
- Shield Von Willebrand Factor Activity (Elisa) Assay
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- July 19, 1996
- Decision date
- November 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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More from Instrumentation Laboratory CO
| 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 |
| 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 Von Willebrand Factor Activity (Elisa) Assay cleared by the FDA?
Shield Von Willebrand Factor Activity (Elisa) Assay (K962825) received a 510(k) decision of Substantially Equivalent on November 15, 1996, 119 days after the submission was received.
What is the product code of K962825?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.