FDA product code JGJ: Photometric Method, Magnesium
JGJ is the FDA product code for photometric method, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel. FDA has cleared 90 510(k) submissions under JGJ, from 64 different applicants. The average 510(k) review took 64 days (median 50). FDA has posted 13 recalls for JGJ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Photometric Method, Magnesium |
| Device class | Class I |
| Regulation | 21 CFR 862.1495 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JGJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 206 |
| 2018 | 2 | 143 |
Compare with all 510(k) review times · Search every JGJ clearance
Top JGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-12-09 |
| Abbott Laboratories | 6 | 2018-09-12 |
| Technicon Instruments Corp. | 6 | 1990-08-29 |
| Randox Laboratories, Ltd. | 2 | 2017-04-28 |
| Abaxis, Inc. | 2 | 2009-10-01 |
59 more applicants have JGJ clearances. See the full list in Caduvo.
Most recent JGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181748 | Abbott Laboratories | Magnesium | 2018-09-12 | 72 |
| K173294 | Abbott Laboratories | Magnesium | 2018-05-18 | 214 |
| K162200 | Randox Laboratories, Ltd. | Randox RX Daytona Plus Magnesium (MG) | 2017-04-28 | 266 |
| K162399 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Magnesium (Mg) | 2017-01-19 | 146 |
| K122302 | Alfa Wassermann Diagnostics Technologies, LLC | ACE MAGNESIUM REGENT | 2012-08-27 | 26 |
Recalls for JGJ devices
13 product recalls in 12 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2024-11-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JGJ?
JGJ is the FDA product code for photometric method, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel.
What device class is JGJ?
Class I, regulation 21 CFR 862.1495. Typical premarket route: 510(k).
How long does a 510(k) take for product code JGJ?
Across 90 cleared submissions the average was 64 days from receipt to decision (median 50).
Which companies have the most JGJ clearances?
Em Diagnostic Systems, Inc. (7); Abbott Laboratories (6); Technicon Instruments Corp. (6); Randox Laboratories, Ltd. (2); Abaxis, Inc. (2).
Have JGJ devices been recalled?
Yes: 13 product recalls across 12 recall events; the most recent began 2024-11-12.
Next steps
- Run an FDA pathway report with predicate devices for product code JGJ
- Run a recall and safety report across every JGJ manufacturer
- Watch product code JGJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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