AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)— 510(k) K041748

Name: FDA 510(k) clearance K041748
Creator: U.S. Food and Drug Administration
Published: 2004-08-09

Substantially Equivalent

Azog, Inc.

FDA 510(k) clearance K041748 for AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM), Substantially Equivalent on 2004-08-09. Applicant: Azog, Inc.. Device class: 2.

Clearance details

Applicant: Azog, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2004-06-29
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Phillipsburg, 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 Azog, Inc.

view all

K022680 — AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)2002-11-01
K022681 — AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)2002-11-01

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