Cleared Traditional

STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010

K893128 · Stanbio Laboratory · Chemistry
Jul 1989
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K893128 is an FDA 510(k) clearance for the STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on July 25, 1989, 91 days after receiving the submission on April 25, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K893128 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date July 25, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDL — Berthelot Indophenol, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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