Ace Magnesium Regent

FDA 510(k) K122302 · Alfa Wassermann Diagnostics Technologies, LLC

Substantially Equivalent

510(k) numberK122302

Submission

Device name
Ace Magnesium Regent
Applicant
Alfa Wassermann Diagnostics Technologies, LLC
West Caldwell, NJ, US
Received
August 1, 2012
Decision date
August 27, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

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

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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
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
K040115Piccolo Magnesium Test SystemJGJ · Traditional Abaxis, Inc.01/30/2004SE

More from Abaxis, Inc.

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K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional 08/19/2013SE
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Questions and answers

When was Ace Magnesium Regent cleared by the FDA?

Ace Magnesium Regent (K122302) received a 510(k) decision of Substantially Equivalent on August 27, 2012, 26 days after the submission was received.

What is the product code of K122302?

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