KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST— 510(k) K062096

Name: FDA 510(k) clearance K062096
Creator: U.S. Food and Drug Administration
Published: 2007-05-07

Substantially Equivalent

Koreamedico Co. , Ltd.

FDA 510(k) clearance K062096 for KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST, Substantially Equivalent on 2007-05-07. Applicant: Koreamedico Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Koreamedico Co. , Ltd.
Product code: Product code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2006-07-24
Decision date: 2007-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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