BLOOD UREA NITROGEN— 510(k) K874532

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K874532 for BLOOD UREA NITROGEN, Substantially Equivalent on 1988-01-05. Applicant: Catachem, Inc.. Device class: 2.

Clearance details

Applicant: Catachem, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1987-11-03
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDW

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K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11
K850937 — UREA1985-06-10

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