Cleared Traditional

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

K992800 · Sigma Diagnostics, Inc. · Chemistry
Sep 1999
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K992800 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 28, 1999, 40 days after receiving the submission on August 19, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K992800 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1999
Decision Date September 28, 1999
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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