HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER— 510(k) K120056
Substantially EquivalentThe Binding Site Group , Ltd.
FDA 510(k) clearance K120056 for HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER, Substantially Equivalent on 2013-04-01. Applicant: The Binding Site Group , Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site Group , Ltd.
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, GB
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