InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
FDA 510(k) clearance K240295 · decided 2024-03-28
Clearance details
- K-number
- K240295
- Device name
- InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
- Applicant
- Instanosis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-01
- Decision date
- 2024-03-28
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- King Of Prussia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.