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FDA 510(k)

Innovita HCG Pregnancy Rapid Combo Test

K-Number: K241919 · 2024-08-02

ApplicantInnovita (Tangshan) Biological Technology Co., Ltd.
Decision Date2024-08-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K241919.

When was Innovita HCG Pregnancy Rapid Combo Test approved by the FDA?

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

What company makes Innovita HCG Pregnancy Rapid Combo Test?

Innovita HCG Pregnancy Rapid Combo Test is manufactured by Innovita (Tangshan) Biological Technology Co., Ltd..

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.

Related Clinical Trials

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Other Devices by Innovita (Tangshan) Biological Technology Co., Ltd.

K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream K250398Innovita Flu A/B Antigen Rapid Test

Related Devices (Code: JHI)

K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd. K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc. K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.

Official Source

View on FDA Database →

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

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