FDA 510(k)

Hemosure Accu-Reader A100

K号: K200754 · 2022-06-02

决定日期2022-06-02

产品代码OOX

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决定实质等同

器械摘要

Hemosure Accu-Reader A100 is the device name listed in this FDA 510(k) record. The listed applicant is W.H.P.M., Inc.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K200754. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hemosure Accu-Reader A100?

Hemosure Accu-Reader A100 is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K200754.

When did Hemosure Accu-Reader A100 receive FDA 510(k) clearance?

Hemosure Accu-Reader A100 received FDA 510(k) clearance on 2022-06-02, under 510(k) number K200754.

Who is the listed applicant for Hemosure Accu-Reader A100?

The FDA 510(k) record lists W.H.P.M., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemosure Accu-Reader A100?

The FDA product code for Hemosure Accu-Reader A100 is OOX.

列明W.H.P.M., Inc.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。

K210327First Sign 多药物测试滴卡，First Sign 多药物测试杯，First Sign 多药物筛查测试滴卡，First Sign 多药物筛查测试杯 K171695First Sign 多药物滴卡测试，First Sign 多药物杯测试，First Sign 毒品滥用滴卡测试大麻，First Sign 毒品滥用杯测试大麻 K160793First Sign 滴卡毒品滥用测试（MDMA，EDDP，去甲替林），First Sign 杯测试毒品滥用（MDMA，EDDP，去甲替林）

官方来源

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