ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
FDA 510(k) clearance K243064 · decided 2024-11-20
Clearance details
- K-number
- K243064
- Device name
- ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
- Applicant
- Eterbio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-27
- Decision date
- 2024-11-20
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Zhuhai, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eterbio
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.