Cleared Traditional

MAGNESIUM REAGENT

K952426 · Schiapparelli Biosystems, Inc. · Chemistry
Aug 1995
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K952426 is an FDA 510(k) clearance for the MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on August 7, 1995, 75 days after receiving the submission on May 24, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K952426 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1995
Decision Date August 07, 1995
Days to Decision 75 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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