FDA product code KZT: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
KZT is the FDA product code for kit, disc, agar gel diffusion, determine serum levels of gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under KZT. The average 510(k) review took 12 days (median 12).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KZT clearance
Top KZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marion Laboratories, Inc. | 1 | 1981-04-29 |
Most recent KZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811067 | Marion Laboratories, Inc. | BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M | 1981-04-29 | 12 |
Recalls for KZT devices
openFDA lists no recalls for product code KZT.
Frequently asked questions
What is FDA product code KZT?
KZT is the FDA product code for kit, disc, agar gel diffusion, determine serum levels of gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is KZT?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZT?
Across 1 cleared submissions the average was 12 days from receipt to decision (median 12).
Which companies have the most KZT clearances?
Marion Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZT
- Run a recall and safety report across every KZT manufacturer
- Watch product code KZT 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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