HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS— 510(k) K081827
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K081827 for HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS, Substantially Equivalent on 2008-12-19. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- 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.