AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
FDA 510(k) clearance K243996 · decided 2025-02-07
Clearance details
- K-number
- K243996
- Device name
- AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
- Applicant
- Assure Tech., LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-12-26
- Decision date
- 2025-02-07
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- NFT
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.