FDA product code JNT: Chromatographic, Phospholipids
JNT is the FDA product code for chromatographic, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JNT, from 3 different applicants. The average 510(k) review took 72 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic, Phospholipids |
| Device class | Class I |
| Regulation | 21 CFR 862.1575 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JNT clearance
Top JNT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Difco Laboratories, Inc. | 1 | 1992-07-30 |
| Sterling Diagnostics, Inc. | 1 | 1991-10-30 |
| Pfizer, Inc. | 1 | 1980-03-12 |
Most recent JNT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922792 | Difco Laboratories, Inc. | ZITHROMAX | 1992-07-30 | 51 |
| K914040 | Sterling Diagnostics, Inc. | PHOSPHOLIPID REAGENT SET | 1991-10-30 | 50 |
| K792349 | Pfizer, Inc. | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | 1980-03-12 | 114 |
Recalls for JNT devices
openFDA lists no recalls for product code JNT.
Frequently asked questions
What is FDA product code JNT?
JNT is the FDA product code for chromatographic, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel.
What device class is JNT?
Class I, regulation 21 CFR 862.1575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JNT?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 51).
Which companies have the most JNT clearances?
Difco Laboratories, Inc. (1); Sterling Diagnostics, Inc. (1); Pfizer, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JNT
- Run a recall and safety report across every JNT manufacturer
- Watch product code JNT 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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