QAB2A IGM ELISA KIT
FDA 510(k) clearance K020694 · decided 2002-04-19
Clearance details
- K-number
- K020694
- Device name
- QAB2A IGM ELISA KIT
- Applicant
- Cheshire Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-04
- Decision date
- 2002-04-19
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- MVS
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Cheshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.