Cleared Traditional

UREA NITROGEN(BUN), COLORIMETRIC METHOD

K864742 · Tech-Co, Inc. · Chemistry
Jan 1987
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K864742 is an FDA 510(k) clearance for the UREA NITROGEN(BUN), COLORIMETRIC METHOD, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by Tech-Co, Inc. (Troy, US). The FDA issued a Cleared decision on January 13, 1987, 40 days after receiving the submission on December 4, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K864742 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1986
Decision Date January 13, 1987
Days to Decision 40 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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