BLOOD UREA NITROGEN (BUN) REAGENT— 510(k) K771312

Name: FDA 510(k) clearance K771312
Creator: U.S. Food and Drug Administration
Published: 1977-08-03

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K771312 for BLOOD UREA NITROGEN (BUN) REAGENT, Substantially Equivalent on 1977-08-03. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1977-07-18
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

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Data sourced from openFDA. This site is unofficial and independent of the FDA.