FDA 510(k)

Innovita HCG Pregnancy Rapid Combo Test

K号: K241919 · 2024-08-02

申请人Innovita (Tangshan) Biological Technology Co., Ltd.

决定日期2024-08-02

产品代码JHI

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Innovita HCG Pregnancy Rapid Combo Test is the device name listed in this FDA 510(k) record. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241919. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Innovita HCG Pregnancy Rapid Combo Test?

Innovita HCG Pregnancy Rapid Combo Test is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K241919.

When did Innovita HCG Pregnancy Rapid Combo Test receive FDA 510(k) clearance?

Innovita HCG Pregnancy Rapid Combo Test received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241919.

Who is the listed applicant for Innovita HCG Pregnancy Rapid Combo Test?

The FDA 510(k) record lists Innovita (Tangshan) Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innovita HCG Pregnancy Rapid Combo Test?

The FDA product code for Innovita HCG Pregnancy Rapid Combo Test is JHI.

列明Innovita (Tangshan) Biological Technology 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。

K250398Innovita Flu A/B Antigen Rapid Test K192843INNOVITA HCG 孕检快速测试条，INNOVITA HCG 孕检快速测试卡，INNOVITA HCG 孕检快速测试中段

相关器械（代码：JHI）

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。

K262299即时查看® hCG 组合 II 条形码测试Alfa Scientific Designs, Inc.K203272Alltest妊娠快速组合测试条Hangzhou AllTest Biotech Co., Ltd.K172322Atellica IM 总hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX人绒毛膜促性腺激素（hCG）早期妊娠测试（中段格式），TrueDX人绒毛膜促性腺激素（hCG）早期妊娠测试（卡式格式），VeriClear早期妊娠测试（中段格式），VeriClear早期妊娠测试（卡式格式）True Diagnostics, Inc.K152768Assure Tech hCG妊娠血清/尿液组合测试条，Assure Tech hCG妊娠血清/尿液组合测试卡Assure Tech. Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。