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FDA 510(k)

Alltest Pregnancy Rapid Combo Test Cassette

K-Number: K203272 · 2022-01-31

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2022-01-31
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alltest Pregnancy Rapid Combo Test Cassette is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-01-31 under approval number K203272. 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 Alltest Pregnancy Rapid Combo Test Cassette?

Alltest Pregnancy Rapid Combo Test Cassette is a medical device that received FDA 510(k) clearance on 2022-01-31. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K203272.

When was Alltest Pregnancy Rapid Combo Test Cassette approved by the FDA?

Alltest Pregnancy Rapid Combo Test Cassette received FDA 510(k) clearance on 2022-01-31, under approval number K203272.

What company makes Alltest Pregnancy Rapid Combo Test Cassette?

Alltest Pregnancy Rapid Combo Test Cassette is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for Alltest Pregnancy Rapid Combo Test Cassette?

The FDA product code for Alltest Pregnancy Rapid Combo Test Cassette is JHI.

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Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx K233417AllTest Fentanyl Urine Test Cassette K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel K241978Shinetell Digital Pregnancy Test

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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. K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology 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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