Magnesium Test Kit
FDA 510(k) K803088 · Mallinckrodt Critical Care
510(k) numberK803088
Submission
- Device name
- Magnesium Test Kit
- Applicant
- Mallinckrodt Critical Care
Mchenry, IL, US - Received
- December 8, 1980
- Decision date
- January 2, 1981
- 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 |
|---|---|---|
| K880343 | Burney Gallbladder Catheter KitFGE · Traditional | 05/01/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | 02/02/1988SE |
| K874514 | Hi-Lo Temp(R) General Purpose Temperature ProbeFLL · Traditional | 01/29/1988SE |
| K874568 | Hi-Lo Temp(R) Model 8700 Patient Temp MonitorFLL · Traditional | 01/06/1988SE |
| K874404 | Hi-Lo Temp(R) Skin Temperature SensorFLL · Traditional | 11/06/1987SE |
| K873461 | Laser-Flex(Tm) Tracheal Tube (Cuffed)BTR · Traditional | 11/06/1987SE |
| K873833 | Thermocouple AdapterFLL · Traditional | 11/03/1987SE |
| K873004 | Guiding CatheterDQO · Traditional | 09/15/1987SE |
| K871204 | Cuffed Tracheal Tube (Multiple)BTR · Traditional | 04/21/1987SE |
| K862666 | Uncuffed Laser Resisteant Tracheal Tube(Tentative)BTR · Traditional | 08/01/1986SE |
Questions and answers
When was Magnesium Test Kit cleared by the FDA?
Magnesium Test Kit (K803088) received a 510(k) decision of Substantially Equivalent on January 2, 1981, 25 days after the submission was received.
What is the product code of K803088?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.