ENA SCREENING CIE KIT FOR DIAGNOSTIC USE— 510(k) K924262
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K924262 for ENA SCREENING CIE KIT FOR DIAGNOSTIC USE, Substantially Equivalent on 1992-12-29. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.