FDA product code JID: Photometric Method, Ammonia
JID is the FDA product code for photometric method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under JID, 1 in the last five years, from 4 different applicants. The average 510(k) review took 83 days (median 64); 188 days on average over the last three years. FDA has posted 1 recall for JID devices.
Classification
| Field | Value |
|---|---|
| Device name | Photometric Method, Ammonia |
| Device class | Class I |
| Regulation | 21 CFR 862.1065 |
| 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 JID
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 188 |
Compare with all 510(k) review times · Search every JID clearance
Top JID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sequitur Health Corp. | 1 | 2026-09-01 |
| Careside, Inc. | 1 | 1999-08-03 |
| Eastman Kodak Company | 1 | 1982-04-01 |
| Wako Pure Chemical Industries, Ltd. | 1 | 1981-12-22 |
Most recent JID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260613 | Sequitur Health Corp. | AMI Plasma Cartridge, AMI | 2026-09-01 | 188 |
| K991371 | Careside, Inc. | CARESIDE AMMONIA | 1999-08-03 | 105 |
| K820723 | Eastman Kodak Company | KODAK EKTACHEM CLINICAL CHEM. NH3 | 1982-04-01 | 16 |
| K813366 | Wako Pure Chemical Industries, Ltd. | AMMONIA TEST | 1981-12-22 | 22 |
Recalls for JID devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-12.
Frequently asked questions
What is FDA product code JID?
JID is the FDA product code for photometric method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel.
What device class is JID?
Class I, regulation 21 CFR 862.1065. Typical premarket route: 510(k).
How long does a 510(k) take for product code JID?
Across 4 cleared submissions the average was 83 days from receipt to decision (median 64).
Which companies have the most JID clearances?
Sequitur Health Corp. (1); Careside, Inc. (1); Eastman Kodak Company (1); Wako Pure Chemical Industries, Ltd. (1).
Have JID devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code JID
- Run a recall and safety report across every JID manufacturer
- Watch product code JID 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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