BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT— 510(k) K042579
Substantially EquivalentThe Binding Site
FDA 510(k) clearance K042579 for BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT, Substantially Equivalent on 2005-07-28. Applicant: The Binding Site. Device class: 2.
Clearance details
- Applicant
- The Binding Site
- Product code
- Code NBT
- Device class
- Class 2
- Regulation
- 21 CFR 866.5785
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Recent devices under product code NBT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.