UREA NITROGEN (BUN) LIQUID REAGENT— 510(k) K981106

Name: FDA 510(k) clearance K981106
Creator: U.S. Food and Drug Administration
Published: 1998-04-16

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K981106 for UREA NITROGEN (BUN) LIQUID REAGENT, Substantially Equivalent on 1998-04-16. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1998-03-26
Decision date: 1998-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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