IN-VITRO DIAGNOSTIC REAGENT SET— 510(k) K930074

Name: FDA 510(k) clearance K930074
Creator: U.S. Food and Drug Administration
Published: 1993-05-11

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K930074 for IN-VITRO DIAGNOSTIC REAGENT SET, Substantially Equivalent on 1993-05-11. Applicant: Horizon Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1993-01-07
Decision date: 1993-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, MI, US

Download summary PDF View on FDA.gov ↗

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