Cleared Traditional

K040115 - PICCOLO MAGNESIUM TEST SYSTEM
(FDA 510(k) Clearance)

K040115 · Abaxis, Inc. · Chemistry

Jan 2004

Decision

10d

Days

Class 1

Risk

K040115 is an FDA 510(k) clearance for the PICCOLO MAGNESIUM TEST SYSTEM. This device is classified as a Photometric Method, Magnesium (Class I — General Controls, product code JGJ).

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on January 30, 2004, 10 days after receiving the submission on January 20, 2004.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number	K040115 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2004
Decision Date	January 30, 2004
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF