FDA product code JZT: Fluorometer
JZT is the FDA product code for fluorometer. It is a Class I device, regulated under 21 CFR 866.4520 and reviewed by the Immunology panel. FDA has cleared 14 510(k) submissions under JZT, from 13 different applicants. The average 510(k) review took 54 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Fluorometer |
| Device class | Class I |
| Regulation | 21 CFR 866.4520 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZT clearance
Top JZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pandex Laboratories, Inc. | 2 | 1986-12-22 |
| Bartels, Inc. | 1 | 1996-09-05 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1988-09-07 |
| Weaver Medical | 1 | 1988-07-12 |
| Whittaker Bioproducts, Inc. | 1 | 1986-10-29 |
8 more applicants have JZT clearances. See the full list in Caduvo.
Most recent JZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962499 | Bartels, Inc. | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | 1996-09-05 | 71 |
| K883349 | Bd Becton Dickinson Vacutainer Systems Preanalytic | QLIA IMMUNOCHEMISTRY SYSTEM | 1988-09-07 | 29 |
| K882677 | Weaver Medical | STAT-20 FLUOROMETER | 1988-07-12 | 14 |
| K864699 | Pandex Laboratories, Inc. | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | 1986-12-22 | 20 |
| K863434 | Whittaker Bioproducts, Inc. | THE FIAX 5000 FLUOROMETER | 1986-10-29 | 55 |
Recalls for JZT devices
openFDA lists no recalls for product code JZT.
Frequently asked questions
What is FDA product code JZT?
JZT is the FDA product code for fluorometer. It is a Class I device, regulated under 21 CFR 866.4520 and reviewed by the Immunology panel.
What device class is JZT?
Class I, regulation 21 CFR 866.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZT?
Across 14 cleared submissions the average was 54 days from receipt to decision (median 42).
Which companies have the most JZT clearances?
Pandex Laboratories, Inc. (2); Bartels, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Weaver Medical (1); Whittaker Bioproducts, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZT
- Run a recall and safety report across every JZT manufacturer
- Watch product code JZT 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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