Cleared Traditional

K860109 - ENZYMATIC UREA NITROGEN REAGENT SET
(FDA 510(k) Clearance)

K860109 · Technostics Intl. · Chemistry

Feb 1986

Decision

24d

Days

Class 2

Risk

K860109 is an FDA 510(k) clearance for the ENZYMATIC UREA NITROGEN REAGENT SET, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 6, 1986, 24 days after receiving the submission on January 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number	K860109 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1986
Decision Date	February 06, 1986
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—