SPAPLUS ANALYZER— 510(k) K100455
Substantially EquivalentThe Binding Site
FDA 510(k) clearance K100455 for SPAPLUS ANALYZER, Substantially Equivalent on 2010-09-03. Applicant: The Binding Site. Device class: 2.
Clearance details
- Applicant
- The Binding Site
- Product code
- Code DBI
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- 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.