Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7
FDA 510(k) K063208 · Diagnostic Chemicals , Ltd.
510(k) numberK063208
Submission
- Device name
- Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- October 23, 2006
- Decision date
- January 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K111915 | Magnesium AssayJGJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 12/02/2011SE |
| K092737 | Easyra MG Reagent, Model 10220JGJ · Special | Medica Corp. | 11/17/2009SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | Abaxis, Inc. | 10/01/2009SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | Abaxis, Inc. | 01/30/2004SE |
More from Abaxis, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070383 | Enzymatic Creatinine Assay (265 Series)JFY · Traditional | 06/22/2007SE |
| K060139 | Crp-Advance Assay, Models 250-20, 250-25DCK · Traditional | 04/28/2006SE |
| K060140 | Crp-Advance Multi Calibrator Set, Model SE-250JIT · Traditional | 04/24/2006SE |
| K051757 | Calcium Advance Assay, Model 145-20, 145-25, 145-20-91CJY · Traditional | 11/10/2005SE |
| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | 07/05/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | 01/07/2005SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | 12/27/2004SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50BLBS · Traditional | 11/23/2004SE |
| K041927 | Ldl/Advance Assay, Cat. No. 279-20, 279-40MRR · Traditional | 11/23/2004SE |
Questions and answers
When was Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7 cleared by the FDA?
Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7 (K063208) received a 510(k) decision of Substantially Equivalent on January 19, 2007, 88 days after the submission was received.
What is the product code of K063208?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.