INVERNESS MEDICAL EARLY PREGNANCY TEST— 510(k) K002049

Name: FDA 510(k) clearance K002049
Creator: U.S. Food and Drug Administration
Published: 2000-07-27

Substantially Equivalent

Selfcare, Inc.

FDA 510(k) clearance K002049 for INVERNESS MEDICAL EARLY PREGNANCY TEST, Substantially Equivalent on 2000-07-27. Applicant: Selfcare, Inc.. Device class: 2.

Clearance details

Applicant: Selfcare, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2000-07-03
Decision date: 2000-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

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K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15

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K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2000-03-17
K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM1999-11-12

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