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FDA 510(k)

Shinetell Digital Pregnancy Test

K-Number: K241978 · 2024-08-13

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2024-08-13
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Shinetell Digital Pregnancy Test is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under approval number K241978. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shinetell Digital Pregnancy Test?

Shinetell Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K241978.

When was Shinetell Digital Pregnancy Test approved by the FDA?

Shinetell Digital Pregnancy Test received FDA 510(k) clearance on 2024-08-13, under approval number K241978.

What company makes Shinetell Digital Pregnancy Test?

Shinetell Digital Pregnancy Test is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for Shinetell Digital Pregnancy Test?

The FDA product code for Shinetell Digital Pregnancy Test is LCX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026)

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) K203272Alltest Pregnancy Rapid Combo Test Cassette 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

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Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

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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