PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup— 510(k) K242077

Name: FDA 510(k) clearance K242077
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Aicheck Biotech, Inc.

FDA 510(k) clearance K242077 for PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup, Substantially Equivalent on 2024-08-14. Applicant: Aicheck Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Aicheck Biotech, Inc.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2024-07-16
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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