QAB2A Igg Elisa Kit HRP
FDA 510(k) K021611 · Cheshire Diagnostics , Ltd.
510(k) numberK021611
Submission
- Device name
- QAB2A Igg Elisa Kit HRP
- Applicant
- Cheshire Diagnostics , Ltd.
Cheshire, GB - Received
- May 16, 2002
- Decision date
- July 12, 2002
- 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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| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV · Traditional | Phadia AB | 06/25/2018SE |
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| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | Phadia US, Inc. | 06/22/2012SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | Instrumentation Laboratory CO | 05/21/2010SE |
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021610 | QAB2A Igm Elisa Kit HRPMSV · Traditional | 07/12/2002SE |
| K021192 | Qaca Igg/Igm Elisa Kit HRPMID · Traditional | 05/16/2002SE |
| K020695 | QAB2A Igg Elisa KitMSV · Traditional | 04/19/2002SE |
| K020694 | QAB2A Igm Elisa KitMVS · Traditional | 04/19/2002SE |
| K020241 | Qaca Igg/Igm Elisa KitMID · Traditional | 03/13/2002SE |
Questions and answers
When was QAB2A Igg Elisa Kit HRP cleared by the FDA?
QAB2A Igg Elisa Kit HRP (K021611) received a 510(k) decision of Substantially Equivalent on July 12, 2002, 57 days after the submission was received.
What is the product code of K021611?
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.