Magnesium Reagent for Demand Analyzer
FDA 510(k) K850381 · Advanced Biomedical Methods, Inc.
510(k) numberK850381
Submission
- Device name
- Magnesium Reagent for Demand Analyzer
- Applicant
- Advanced Biomedical Methods, Inc.
Niles, IL, US - Received
- January 31, 1985
- Decision date
- March 1, 1985
- 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 |
More from Clinical Data, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945353 | Clarit(Tm)JKA · Traditional | 12/09/1994SE |
| K880949 | Single Reagent Calcium for Demand AnalyzerCJY · Traditional | 04/05/1988SE |
| K864866 | Resubmission of the Kleerzit ReagentJKA · Traditional | 03/16/1987SE |
| K852784 | Alkaline PhosphataseCJE · Traditional | 07/22/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | 07/22/1985SE |
| K852027 | GGTP Reagent/Serum Iron/Salicylate Demand AnalyzerDKJ · Traditional | 05/29/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | 03/01/1985SE |
| K850379 | Direct Bilirubin for Demand AnalyzerCIG · Traditional | 03/01/1985SE |
| K850378 | LDH Reagent for Demand AnalyzerCFJ · Traditional | 03/01/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | 01/03/1985SE |
Questions and answers
When was Magnesium Reagent for Demand Analyzer cleared by the FDA?
Magnesium Reagent for Demand Analyzer (K850381) received a 510(k) decision of Substantially Equivalent on March 1, 1985, 29 days after the submission was received.
What is the product code of K850381?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.