510(k) K242498

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC by Aicheck Biotech, Inc. — Product Code NFT

K242498 is an FDA 510(k) premarket notification submitted by Aicheck Biotech, Inc. for the device "Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC". The FDA issued a decision of Substantially Equivalent on October 1, 2024. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Aicheck Biotech, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2024
Date Received
August 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type