UREA NITROGEN TEST— 510(k) K781899

Substantially Equivalent

Wako Intl., Inc.

FDA 510(k) clearance K781899 for UREA NITROGEN TEST, Substantially Equivalent on 1978-12-20. Applicant: Wako Intl., Inc.. Device class: 2.

Clearance details

Applicant: Wako Intl., Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1978-11-13
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDL

K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT1990-02-16
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

More clearances from Wako Intl., Inc.

K790768 — WAKO CHOLESTEROL TEST1979-05-23
K781629 — SERI-SEP SERUM/PLASMA ISLOLATOR1978-10-27
K781342 — GLUCOSE TEST1978-08-31

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