Cleared Traditional

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123

K891912 · American Research Products Co. · Chemistry
Jun 1989
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K891912 is an FDA 510(k) clearance for the AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 19, 1989, 84 days after receiving the submission on March 27, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K891912 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1989
Decision Date June 19, 1989
Days to Decision 84 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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