Magnesium Assay
FDA 510(k) K111915 · Sekisui Diagnostics P.E.I., Inc.
510(k) numberK111915
Submission
- Device name
- Magnesium Assay
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
Prince Edward Island, CA - Received
- July 6, 2011
- Decision date
- December 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K181748 | MagnesiumJGJ · Traditional | Abbott Laboratories | 09/12/2018SE |
| K173294 | MagnesiumJGJ · Traditional | Abbott Laboratories | 05/18/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | Randox Laboratories, Ltd. | 04/28/2017SE |
| K162399 | Atellica CH Magnesium (Mg)JGJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/19/2017SE |
| K122302 | Ace Magnesium RegentJGJ · Special | Alfa Wassermann Diagnostics Technologies, LLC | 08/27/2012SE |
| K092737 | Easyra MG Reagent, Model 10220JGJ · Special | Medica Corp. | 11/17/2009SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | Abaxis, Inc. | 10/01/2009SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | Diagnostic Chemicals , Ltd. | 01/19/2007SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | Abaxis, Inc. | 01/30/2004SE |
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| K173206 | SEKURE HbA1c AssayPDJ · Traditional | 07/12/2018SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | 12/08/2016SE |
Questions and answers
When was Magnesium Assay cleared by the FDA?
Magnesium Assay (K111915) received a 510(k) decision of Substantially Equivalent on December 2, 2011, 149 days after the submission was received.
What is the product code of K111915?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.