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FDA 510(k)

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

K-Number: K250117 · 2025-02-13

ApplicantAssure Tech., LLC
Decision Date2025-02-13
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is a medical device manufactured by Assure Tech., LLC. It received FDA 510(k) clearance on 2025-02-13 under approval number K250117. 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 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Assure Tech., LLC. The 510(k) number is K250117.

When was FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette approved by the FDA?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette received FDA 510(k) clearance on 2025-02-13, under approval number K250117.

What company makes FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is manufactured by Assure Tech., LLC.

What is the FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

The FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is LCX.

Related Clinical Trials

NCT06645106 Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department RECRUITING NCT04762316 Composition for Treating Uterine Fibroid (SB-UF) COMPLETED NCT07498153 Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting COMPLETED

Other Devices by Assure Tech., LLC

K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

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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