QAB2A Igm Elisa Kit
FDA 510(k) K020694 · Cheshire Diagnostics , Ltd.
510(k) numberK020694
Submission
- Device name
- QAB2A Igm Elisa Kit
- Applicant
- Cheshire Diagnostics , Ltd.
Cheshire, GB - Received
- March 4, 2002
- Decision date
- April 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MVS – Kit, Typing, Hla-Dqb
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
More from Cheshire Diagnostics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K021611 | QAB2A Igg Elisa Kit HRPMSV · Traditional | 07/12/2002SE |
| 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 |
| K020241 | Qaca Igg/Igm Elisa KitMID · Traditional | 03/13/2002SE |
Questions and answers
When was QAB2A Igm Elisa Kit cleared by the FDA?
QAB2A Igm Elisa Kit (K020694) received a 510(k) decision of Substantially Equivalent on April 19, 2002, 46 days after the submission was received.
What is the product code of K020694?
The FDA product code is MVS – Kit, Typing, Hla-Dqb, a Class II (moderate risk) device regulated under 21 CFR 866.5660.