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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 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 2022-01-31 under 510(k) 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. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K203272.

When did Alltest Pregnancy Rapid Combo Test Cassette receive FDA 510(k) clearance?

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

Who is the listed applicant for Alltest Pregnancy Rapid Combo Test Cassette?

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 Pregnancy Rapid Combo Test Cassette?

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

Other records listing Hangzhou AllTest Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260342AllTest Strep A Rapid TestK252607AllTest Urinary Tract Infection TestK251053Shinetell PlusTM Digital Early Pregnancy TestK250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK242576AllTest Viral Transport MediumK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.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.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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