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FDA 510(k)

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

K-Number: K242077 · 2024-08-14

ApplicantAicheck Biotech, Inc.
Decision Date2024-08-14
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Aicheck Biotech, Inc.. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K242077. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup?

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Aicheck Biotech, Inc.. The 510(k) number is K242077.

When did PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup receive FDA 510(k) clearance?

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup received FDA 510(k) clearance on 2024-08-14, under 510(k) number K242077.

Who is the listed applicant for PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup?

The FDA 510(k) record lists Aicheck Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup?

The FDA product code for PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup is NFT.

Other records listing Aicheck Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC

Related Devices (Code: NFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLCK261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLCK252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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