MG Reagent

FDA 510(k) K852005 · Alpkem Corp.

Substantially Equivalent

510(k) numberK852005

Submission

Device name
MG Reagent
Applicant
Alpkem Corp.
Clackamas, OR, US
Received
May 7, 1985
Decision date
June 25, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JGJ – Photometric Method, Magnesium
Device class
Class I (low risk)
Regulation
21 CFR 862.1495
Specialty
Clinical Chemistry

Other 510(k)s with product code JGJ

510(k)DeviceApplicantDecision
K181748MagnesiumJGJ · Traditional Abbott Laboratories09/12/2018SE
K173294MagnesiumJGJ · Traditional Abbott Laboratories05/18/2018SE
K162200Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional Randox Laboratories, Ltd.04/28/2017SE
K162399Atellica CH Magnesium (Mg)JGJ · Traditional Siemens Healthcare Diagnostics, Inc.01/19/2017SE
K122302Ace Magnesium RegentJGJ · Special Alfa Wassermann Diagnostics Technologies, LLC08/27/2012SE
K111915Magnesium AssayJGJ · Traditional Sekisui Diagnostics P.E.I., Inc.12/02/2011SE
K092737Easyra MG Reagent, Model 10220JGJ · Special Medica Corp.11/17/2009SE
K091910Piccolo Magnesium Test SystemJGJ · Special Abaxis, Inc.10/01/2009SE
K063208Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional Diagnostic Chemicals , Ltd.01/19/2007SE
K040508Vitalab Magnesium ReagentJGJ · Traditional Clinical Data, Inc.03/08/2004SE

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Questions and answers

When was MG Reagent cleared by the FDA?

MG Reagent (K852005) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 49 days after the submission was received.

What is the product code of K852005?

The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.