BUN-300/BUN-500 UREA NITROGEN REAGENT— 510(k) K934533

Name: FDA 510(k) clearance K934533
Creator: U.S. Food and Drug Administration
Published: 1993-11-26

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K934533 for BUN-300/BUN-500 UREA NITROGEN REAGENT, Substantially Equivalent on 1993-11-26. Applicant: Horizon Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1993-09-17
Decision date: 1993-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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