FREELITE HUMAN LAMBDA FREE KIT
FDA 510(k) clearance K140396 · decided 2014-04-16
Clearance details
- K-number
- K140396
- Device name
- FREELITE HUMAN LAMBDA FREE KIT
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-18
- Decision date
- 2014-04-16
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DEH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.