Cleared Traditional

JAS MAGNESIUM REAGENT

K003835 · Jas Diagnostics, Inc. · Chemistry
Mar 2001
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K003835 is an FDA 510(k) clearance for the JAS MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on March 23, 2001, 101 days after receiving the submission on December 12, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K003835 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2000
Decision Date March 23, 2001
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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