Cleared Traditional

K040508 - VITALAB MAGNESIUM REAGENT
(FDA 510(k) Clearance)

K040508 · Clinical Data, Inc. · Chemistry

Mar 2004

Decision

10d

Days

Class 1

Risk

K040508 is an FDA 510(k) clearance for the VITALAB MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 8, 2004, 10 days after receiving the submission on February 27, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number	K040508 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2004
Decision Date	March 08, 2004
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF