Cleared Traditional

K874532 - BLOOD UREA NITROGEN
(FDA 510(k) Clearance)

K874532 · Catachem, Inc. · Chemistry

Jan 1988

Decision

63d

Days

Class 2

Risk

K874532 is an FDA 510(k) clearance for the BLOOD UREA NITROGEN, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on January 5, 1988, 63 days after receiving the submission on November 3, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number	K874532 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1987
Decision Date	January 05, 1988
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—