ANTI-TPO EIA DIAGNOSTIC TEST KIT— 510(k) K984163
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K984163 for ANTI-TPO EIA DIAGNOSTIC TEST KIT, Substantially Equivalent on 1999-02-02. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- 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.