Cleared Traditional

BUN REAGENT KIT

K873132 · A-Kem, Inc. · Chemistry
Oct 1987
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K873132 is an FDA 510(k) clearance for the BUN REAGENT KIT, a Conductivity Rate, Urea Nitrogen (Class II — Special Controls, product code LFP), submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on October 23, 1987, 74 days after receiving the submission on August 10, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K873132 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1987
Decision Date October 23, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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