Magnesium Procedure

FDA 510(k) K861668 · Data Medical Associates, Inc.

Substantially Equivalent

510(k) numberK861668

Submission

Device name
Magnesium Procedure
Applicant
Data Medical Associates, Inc.
Arlington, TX, US
Received
April 30, 1986
Decision date
May 27, 1986
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

More from Clinical Data, Inc.

510(k)DeviceDecision
K993098Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional 10/08/1999SE
K971113Dma Triglycerides ProceduresCDT · Traditional 05/29/1997SE
K961919Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional 07/01/1996SE
K955796Iron Calibrator & Calibration Verification SetJJX · Traditional 02/29/1996SE
K955302Serum Bicarbonate/Carbon DioxideKHS · Traditional 02/29/1996SE
K955300Total Bilirubin ProcedureCIG · Traditional 12/20/1995SE
K952437Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional 10/03/1995SE
K946161Dma Total Cholesterol ProcedureCHH · Traditional 08/23/1995SE
K946354Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional 05/08/1995SE
K946355Dma Albumin ProcedureCIX · Traditional 03/01/1995SE

Questions and answers

When was Magnesium Procedure cleared by the FDA?

Magnesium Procedure (K861668) received a 510(k) decision of Substantially Equivalent on May 27, 1986, 27 days after the submission was received.

What is the product code of K861668?

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