FaStep Early Pregnancy Rapid Test Strip +2 more— 510(k) K243573

Name: FDA 510(k) clearance K243573
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K243573 for FaStep Early Pregnancy Rapid Test Strip +2 more, Substantially Equivalent on 2025-01-15. Applicant: Assure Tech., LLC. Device class: 2.

Clearance details

Device name as filed: FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
Applicant: Assure Tech., LLC
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2024-11-19
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

view all

K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test2025-09-09
K251053 — Shinetell PlusTM Digital Early Pregnancy Test2025-07-15
K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette2025-02-13
K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream2025-01-31
K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip2024-12-20

More clearances from Assure Tech., LLC

view all

K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup2026-07-17
K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test2026-06-05
K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup2025-08-15
K243996 — AssureTech Panel Dip Tests +3 more2025-02-07
K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)2024-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.