FREELITE HUMAN KAPPA AND LAMBDA KITS— 510(k) K040009
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K040009 for FREELITE HUMAN KAPPA AND LAMBDA KITS, Substantially Equivalent on 2004-03-11. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, 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
- Santa Monica, CA, US
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More clearances from The Binding Site, Ltd.
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- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
Data sourced from openFDA. This site is unofficial and independent of the FDA.