ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test— 510(k) K243064
Substantially EquivalentEterbio, Inc.
FDA 510(k) clearance K243064 for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test, Substantially Equivalent on 2024-11-20. Applicant: Eterbio, Inc.. Device class: 2.
Clearance details
- Applicant
- Eterbio, Inc.
- Product code
- Code NGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhuhai, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.