Roche Reagent for Magnesium
FDA 510(k) K901758 · Roche Diagnostic Systems, Inc.
510(k) numberK901758
Submission
- Device name
- Roche Reagent for Magnesium
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- April 18, 1990
- Decision date
- May 23, 1990
- 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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Questions and answers
When was Roche Reagent for Magnesium cleared by the FDA?
Roche Reagent for Magnesium (K901758) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 35 days after the submission was received.
What is the product code of K901758?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.