QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3— 510(k) K001249

Name: FDA 510(k) clearance K001249
Creator: U.S. Food and Drug Administration
Published: 2000-11-02

Substantially Equivalent

Consolidated Technologies of Wisconsin

FDA 510(k) clearance K001249 for QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3, Substantially Equivalent on 2000-11-02. Applicant: Consolidated Technologies of Wisconsin. Device class: 1.

Clearance details

Applicant: Consolidated Technologies of Wisconsin
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2000-04-12
Decision date: 2000-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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