AMRESCO UREA NITROGEN REAGENT SET— 510(k) K830555

Name: FDA 510(k) clearance K830555
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K830555 for AMRESCO UREA NITROGEN REAGENT SET, Substantially Equivalent on 1983-03-24. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1983-02-23
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDQ

view all

K203771 — Urea Nitrogen22022-05-31
K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER2014-09-02
K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS2011-04-21
K073295 — UREA/BUN, SCAL, NORTROL, ABTROL2008-05-29
K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP2007-10-12

More clearances from Amresco, Inc.

view all

K905618 — GGT REAGENT1991-02-26
K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/71761991-01-17
K905684 — ALKALINE PHOSPHATASE1990-12-28
K905544 — MAGNESIUM REAGENT1990-12-27
K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,71161990-12-11

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