MID STREAM PREGNANCY TEST— 510(k) K023037

Name: FDA 510(k) clearance K023037
Creator: U.S. Food and Drug Administration
Published: 2003-04-09

Substantially Equivalent

Advanced Diagnostics, Inc.

FDA 510(k) clearance K023037 for MID STREAM PREGNANCY TEST, Substantially Equivalent on 2003-04-09. Applicant: Advanced Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Diagnostics, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2002-09-12
Decision date: 2003-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: So. Plainfield, NJ, 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
K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15

More clearances from Advanced Diagnostics, Inc.

view all

K013886 — AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)2002-05-10
K013291 — ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)2001-11-14
K001510 — OS-2000 OPTICAL SONOGRAPHY SYSTEM2000-11-30

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