FDA product code NGJ: Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
NGJ is the FDA product code for test, nitrite, urinary, non-quantitative, over the counter. It is a Class I device, regulated under 21 CFR 862.1510 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under NGJ. The average 510(k) review took 551 days (median 551). FDA has posted 1 recall for NGJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1510 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NGJ clearance
Top NGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ind Diagnostic, Inc. | 1 | 2012-04-17 |
Most recent NGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103037 | Ind Diagnostic, Inc. | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | 2012-04-17 | 551 |
Recalls for NGJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-22.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code NGJ?
NGJ is the FDA product code for test, nitrite, urinary, non-quantitative, over the counter. It is a Class I device, regulated under 21 CFR 862.1510 and reviewed by the Clinical Toxicology panel.
What device class is NGJ?
Class I, regulation 21 CFR 862.1510. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGJ?
Across 1 cleared submissions the average was 551 days from receipt to decision (median 551).
Which companies have the most NGJ clearances?
Ind Diagnostic, Inc. (1).
Have NGJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NGJ
- Run a recall and safety report across every NGJ manufacturer
- Watch product code NGJ 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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