HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
FDA 510(k) clearance K123256 · decided 2013-07-03
Clearance details
- K-number
- K123256
- Device name
- HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-18
- Decision date
- 2013-07-03
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- DEM
- Device class
- 2
- Regulation number
- 866.5130
- 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.