FDA product code JGZ: O-Phthalaldehyde, Urea Nitrogen
JGZ is the FDA product code for o-phthalaldehyde, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under JGZ, from 10 different applicants. The average 510(k) review took 70 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | O-Phthalaldehyde, Urea Nitrogen |
| Device class | Class II |
| Regulation | 21 CFR 862.1770 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JGZ clearance
Top JGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 2 | 1990-10-12 |
| Heraeus Kulzer, Inc. | 1 | 1989-01-23 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1986-11-24 |
| Pharmacia, Inc. | 1 | 1984-11-01 |
| Sclavo, Inc. | 1 | 1984-03-19 |
5 more applicants have JGZ clearances. See the full list in Caduvo.
Most recent JGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904049 | Roche Diagnostic Systems, Inc. | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | 1990-10-12 | 38 |
| K896236 | Roche Diagnostic Systems, Inc. | COBAS READY BUN REAGENT | 1990-02-27 | 120 |
| K883327 | Heraeus Kulzer, Inc. | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | 1989-01-23 | 168 |
| K863901 | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQ UREA NITROGEN | 1986-11-24 | 48 |
| K842772 | Pharmacia, Inc. | PHARMACIA B2-MICRO RIA | 1984-11-01 | 108 |
Recalls for JGZ devices
openFDA lists no recalls for product code JGZ.
Frequently asked questions
What is FDA product code JGZ?
JGZ is the FDA product code for o-phthalaldehyde, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel.
What device class is JGZ?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code JGZ?
Across 11 cleared submissions the average was 70 days from receipt to decision (median 48).
Which companies have the most JGZ clearances?
Roche Diagnostic Systems, Inc. (2); Heraeus Kulzer, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Pharmacia, Inc. (1); Sclavo, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGZ
- Run a recall and safety report across every JGZ manufacturer
- Watch product code JGZ 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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