K233019
- 510(k) number
- K233019
- Device name
- AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- DKZ — Enzyme Immunoassay, Amphetamine
- Decision date
- 2023-12-13
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233019.pdf
Official FDA record: K233019
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.