FDA 510(k)

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

K号: K244043 · 2025-02-27

决定日期2025-02-27

产品代码NFT

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器械摘要

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K244043. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K244043.

When did AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup receive FDA 510(k) clearance?

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup received FDA 510(k) clearance on 2025-02-27, under 510(k) number K244043.

Who is the listed applicant for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

The FDA 510(k) record lists Hangzhou AllTest Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

The FDA product code for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is NFT.

列明Hangzhou AllTest Biotech Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260342AllTest Strep A Rapid Test K252607AllTest 尿路感染测试 K251053Shinetell PlusTM 数字型早孕测试 K242576AllTest 病毒运输培养基 K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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相关器械（代码：NFT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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