UREA NITROGEN REAGENT SET— 510(k) K860419

Name: FDA 510(k) clearance K860419
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860419 for UREA NITROGEN REAGENT SET, Substantially Equivalent on 1986-02-11. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-02-04
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, 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
K850937 — UREA1985-06-10

More clearances from Sterling Diagnostics, Inc.

view all

K921412 — MICROPROTEIN REAGENT SET1993-01-21
K914609 — TRIGLYCERIDES REAGENT SET1991-11-07
K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

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