510(k) K020694
- Device
- QAB2A IGM ELISA KIT
- Applicant
- Cheshire Diagnostics , Ltd.
- 510(k) number
- K020694
- Product code
- MVS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-19
- Date received
- 2002-03-04
- Regulation
- 866.5660
- Classification name
- Kit, Typing, Hla-Dqb
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- NEIL B STRINGER
- Address
- Management Centre, Inward Way Ellesmere Port Cheshire GB CH65 3EN CH65 3EN
Source Documents
510(k) summary PDF not indicated by FDA