ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)— 510(k) K060019

Name: FDA 510(k) clearance K060019
Creator: U.S. Food and Drug Administration
Published: 2006-02-17

Substantially Equivalent

Artron Laboratories, Inc.

FDA 510(k) clearance K060019 for ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM), Substantially Equivalent on 2006-02-17. Applicant: Artron Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Artron Laboratories, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2006-01-04
Decision date: 2006-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, British Columbia, CA

Download summary PDF View on FDA.gov ↗

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