Cleared Traditional

RAICHEM BUN RATE REAGENT

K012649 · Hemagen Diagnostics, Inc. · Chemistry
Oct 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K012649 is an FDA 510(k) clearance for the RAICHEM BUN RATE REAGENT, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on October 15, 2001, 63 days after receiving the submission on August 13, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K012649 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2001
Decision Date October 15, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

Similar Devices — CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 116
Urea Nitrogen2
K203771 · Abbott Ireland Diagnostics Division · May 2022
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
K140690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2014
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675 · Medica Corp. · Apr 2011
UREA/BUN, SCAL, NORTROL, ABTROL
K073295 · Thermofisher Scientific OY · May 2008
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · Horiba Abx · Oct 2007
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120 · Teco Diagnostics · Mar 2006