Determination of Magnesium in Serum or
FDA 510(k) K841259 · Sigma Chemical Co.
510(k) numberK841259
Submission
- Device name
- Determination of Magnesium in Serum or
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- March 26, 1984
- Decision date
- May 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
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Questions and answers
When was Determination of Magnesium in Serum or cleared by the FDA?
Determination of Magnesium in Serum or (K841259) received a 510(k) decision of Substantially Equivalent on May 7, 1984, 42 days after the submission was received.
What is the product code of K841259?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.