HOSPITAL LAB IN-HOME EARLY PREG TEST— 510(k) K832593

Name: FDA 510(k) clearance K832593
Creator: U.S. Food and Drug Administration
Published: 1984-01-11

Substantially Equivalent

Aicl-Pack, Inc.

FDA 510(k) clearance K832593 for HOSPITAL LAB IN-HOME EARLY PREG TEST, Substantially Equivalent on 1984-01-11. Applicant: Aicl-Pack, Inc.. Device class: 2.

Clearance details

Applicant: Aicl-Pack, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-08-02
Decision date: 1984-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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