Cleared Traditional

KING DIAGNOSTICS UREA NITROGEN REAGENT

K922969 · King Diagnostics, Inc. · Chemistry
Oct 1992
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K922969 is an FDA 510(k) clearance for the KING DIAGNOSTICS UREA NITROGEN REAGENT, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 13, 1992, 116 days after receiving the submission on June 19, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K922969 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1992
Decision Date October 13, 1992
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDN — Urease, Photometric, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

Similar Devices — CDN Urease, Photometric, Urea Nitrogen

All 15
VITROS XT Chemistry Products UREA-CREA Slides
K190326 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · Hitachi Chemical Diagnostics, Inc. · Oct 2013
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
K123322 · Alfa Wassermann Diagnostics Technologies, LLC · May 2013
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · Alfa Wassermann Diagnostic Technologies, Inc. · Aug 2012
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
K103615 · Alfa Wassermann Diagnostic Technologies, Inc. · Sep 2011
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885 · Ortho-Clinical Diagnostics, Inc. · Jul 2000