Cleared Traditional

CARESIDE MG

K991717 · Careside, Inc. · Chemistry
Aug 1999
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K991717 is an FDA 510(k) clearance for the CARESIDE MG, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on August 10, 1999, 82 days after receiving the submission on May 20, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K991717 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1999
Decision Date August 10, 1999
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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