Cleared Traditional

K842443 - AXIOM STABLE II TRIGLYCERIDES TEST
(FDA 510(k) Clearance)

K842443 · Axiom, Inc. · Chemistry

Sep 1984

Decision

84d

Days

Class 1

Risk

K842443 is an FDA 510(k) clearance for the AXIOM STABLE II TRIGLYCERIDES TEST. This device is classified as a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT).

Submitted by Axiom, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984, 84 days after receiving the submission on June 21, 1984.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number	K842443 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 1984
Decision Date	September 13, 1984
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—