K242077

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

510(k) number
K242077
Device name
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
Applicant
Aicheck Biotech, Inc. CA · US
Product code
NFT — Test, Amphetamine, Over The Counter
Decision date
2024-08-14
Date received
2024-07-16
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain

Also available from FDA: K242077.pdf

Official FDA record: K242077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.