FDA product code NTZ: Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
NTZ is the FDA product code for strip, dialysate, ph, bicarbonate, glucose, acid, indicator. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NTZ. The average 510(k) review took 222 days (median 222).
Definition
Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NTZ clearance
Top NTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Serim Research Corp. | 1 | 2005-06-13 |
Most recent NTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043031 | Serim Research Corp. | SERIM DIALYSATE MONITOR TEST STRIP | 2005-06-13 | 222 |
Recalls for NTZ devices
openFDA lists no recalls for product code NTZ.
Frequently asked questions
What is FDA product code NTZ?
NTZ is the FDA product code for strip, dialysate, ph, bicarbonate, glucose, acid, indicator. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is NTZ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTZ?
Across 1 cleared submissions the average was 222 days from receipt to decision (median 222).
Which companies have the most NTZ clearances?
Serim Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTZ
- Run a recall and safety report across every NTZ manufacturer
- Watch product code NTZ 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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