FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER— 510(k) K033811
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K033811 for FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER, Substantially Equivalent on 2004-01-30. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code DEH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.