HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS— 510(k) K140664
Substantially EquivalentThe Binding Site Group , Ltd.
FDA 510(k) clearance K140664 for HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS, Substantially Equivalent on 2014-04-16. Applicant: The Binding Site Group , Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site Group , Ltd.
- Product code
- Code DEB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5620
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, GB
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