SERUM, BLOOD UREA NITIOGEN— 510(k) K781885

Name: FDA 510(k) clearance K781885
Creator: U.S. Food and Drug Administration
Published: 1978-12-20

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K781885 for SERUM, BLOOD UREA NITIOGEN, Substantially Equivalent on 1978-12-20. Applicant: Fisher Scientific Co., LLC. Device class: 2.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1978-11-07
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 CDW

view all

K874532 — BLOOD UREA NITROGEN1988-01-05
K871320 — FLOW-PAC UREA NITROGEN REAGENT SET 2214, 28141987-04-22
K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #13461986-10-01
K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

More clearances from Fisher Scientific Co., LLC

view all

K930415 — MICROHEMATOCRIT ROTOR1993-03-23
K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE1992-03-11
K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE1992-01-08
K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 11989-03-08
K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II1988-05-16

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