UREA NITROGEN (GLDH) REAGENT SET (UV)— 510(k) K862210

Name: FDA 510(k) clearance K862210
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K862210 for UREA NITROGEN (GLDH) REAGENT SET (UV), Substantially Equivalent on 1986-07-01. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-06-10
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, 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 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.