HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
FDA 510(k) clearance K113823 · decided 2013-03-27
Clearance details
- K-number
- K113823
- Device name
- HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-27
- Decision date
- 2013-03-27
- Days to decision
- 456 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Birmingham, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.