RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT— 510(k) K896845

Name: FDA 510(k) clearance K896845
Creator: U.S. Food and Drug Administration
Published: 1990-02-16

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K896845 for RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT, Substantially Equivalent on 1990-02-16. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1989-12-06
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDL

view all

K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #20101989-07-25
K871651 — COLORIMETRIC BUN REAGENT KIT1987-05-12
K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD1987-01-13
K863889 — UREA NITROGEN TEST1986-11-24
K863076 — UREAFAST1986-09-09

More clearances from Reagents Applications, Inc.

view all

K982056 — RAICHEM CO2 REAGENT1998-06-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENT1997-09-24
K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1992-07-30
K915191 — RAI-TROL ELEVATED LIPIDS CONTROL1991-12-18
K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT1991-09-25

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