Cleared Traditional

RAICHEM(TM) MAGNESIUM REAGENT

K874822 · Reagents Applications, Inc. · Chemistry
Jan 1988
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K874822 is an FDA 510(k) clearance for the RAICHEM(TM) MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on January 21, 1988, 58 days after receiving the submission on November 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K874822 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1987
Decision Date January 21, 1988
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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