Cleared Traditional

RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC

K880880 · Reagents Applications, Inc. · Chemistry
May 1988
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K880880 is an FDA 510(k) clearance for the RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC, 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 May 27, 1988, 86 days after receiving the submission on March 2, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K880880 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1988
Decision Date May 27, 1988
Days to Decision 86 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

Similar Devices — JGJ Photometric Method, Magnesium

All 89
Magnesium
K181748 · Abbott Laboratories · Sep 2018
Magnesium
K173294 · Abbott Laboratories · May 2018
Randox RX Daytona Plus Magnesium (MG)
K162200 · Randox Laboratories, Ltd. · Apr 2017
Atellica CH Magnesium (Mg)
K162399 · Siemens Healthcare Diagnostics, Inc. · Jan 2017
ACE MAGNESIUM REGENT
K122302 · Alfa Wassermann Diagnostics Technologies, LLC · Aug 2012
MAGNESIUM ASSAY
K111915 · Sekisui Diagnostics P.E.I., Inc. · Dec 2011