AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583— 510(k) K900394

Name: FDA 510(k) clearance K900394
Creator: U.S. Food and Drug Administration
Published: 1990-04-11

Substantially Equivalent

American Research Products Co.

FDA 510(k) clearance K900394 for AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583, Substantially Equivalent on 1990-04-11. Applicant: American Research Products Co.. Device class: 2.

Clearance details

Applicant: American Research Products Co.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1990-01-29
Decision date: 1990-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, 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 American Research Products Co.

view all

K942984 — BUN REAGENT1995-03-01
K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN1990-07-19
K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 77261990-05-31
K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/74631990-05-31
K900827 — COLORIMETRIC CHLORIDE PRODUCT #43141251990-05-02

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