Cleared Traditional

HICHEM BUN REAGENT

K992847 · Elan Holdings, Inc. · Chemistry
Oct 1999
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K992847 is an FDA 510(k) clearance for the HICHEM BUN REAGENT, a Conductivity Rate, Urea Nitrogen (Class II — Special Controls, product code LFP), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 14, 1999, 51 days after receiving the submission on August 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K992847 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1999
Decision Date October 14, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFP — Conductivity Rate, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770