FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT— 510(k) K070900
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K070900 for FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT, Substantially Equivalent on 2007-11-30. Applicant: The Binding Site, Ltd..
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code DFH
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.