BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.— 510(k) K991803
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K991803 for BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT., Substantially Equivalent on 2000-05-05. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- 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.