REAGENT, BUN (UREA NITROGEN) DETERM.— 510(k) K760478

Name: FDA 510(k) clearance K760478
Creator: U.S. Food and Drug Administration
Published: 1976-10-29

Substantially Equivalent

Simmler & Son, Inc.

FDA 510(k) clearance K760478 for REAGENT, BUN (UREA NITROGEN) DETERM., Substantially Equivalent on 1976-10-29. Applicant: Simmler & Son, Inc.. Device class: 2.

Clearance details

Applicant: Simmler & Son, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1976-08-17
Decision date: 1976-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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