Cleared Traditional

UREA NITROGEN-BUN-REAGENTS B6360-12

K831625 · American Scientific Products · Chemistry
Jul 1983
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K831625 is an FDA 510(k) clearance for the UREA NITROGEN-BUN-REAGENTS B6360-12, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983, 48 days after receiving the submission on May 20, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K831625 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1983
Decision Date July 07, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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