SYNERMED UREA NITROGEN REAGENT KIT— 510(k) K911248

Name: FDA 510(k) clearance K911248
Creator: U.S. Food and Drug Administration
Published: 1991-06-03

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K911248 for SYNERMED UREA NITROGEN REAGENT KIT, Substantially Equivalent on 1991-06-03. Applicant: Synermed, Inc.. Device class: 2.

Clearance details

Applicant: Synermed, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1991-03-21
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

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