Cleared Traditional

K864231 - U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
(FDA 510(k) Clearance)

K864231 · U. S. Diagnostics, Inc. · Chemistry

Dec 1986

Decision

37d

Days

Class 1

Risk

K864231 is an FDA 510(k) clearance for the U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on December 4, 1986, 37 days after receiving the submission on October 28, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number	K864231 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1986
Decision Date	December 04, 1986
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—