BLOOD UREA NITROGEN BUN— 510(k) K771830

Name: FDA 510(k) clearance K771830
Creator: U.S. Food and Drug Administration
Published: 1977-10-25

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K771830 for BLOOD UREA NITROGEN BUN, Substantially Equivalent on 1977-10-25. Applicant: Gamma Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1977-09-21
Decision date: 1977-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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