FDA product code JQT: Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
JQT is the FDA product code for densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica. It is a Class I device, regulated under 21 CFR 862.2400 and reviewed by the Clinical Chemistry panel. FDA has cleared 18 510(k) submissions under JQT, from 13 different applicants. The average 510(k) review took 61 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Device class | Class I |
| Regulation | 21 CFR 862.2400 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQT clearance
Top JQT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corning Medical & Scientific | 3 | 1985-03-12 |
| Astral Medical Systems | 2 | 1985-09-25 |
| Logos Scientific, Inc. | 2 | 1984-09-10 |
| Transidyne General Corp. | 2 | 1981-01-09 |
| Arlington Scientific, Inc. | 1 | 2011-11-09 |
8 more applicants have JQT clearances. See the full list in Caduvo.
Most recent JQT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111356 | Arlington Scientific, Inc. | ASIMANAGER - AT | 2011-11-09 | 177 |
| K944185 | Isolab, Inc. | ISOSCAN | 1994-11-17 | 83 |
| K915332 | Ciba Corning Diagnostics Corp. | MODEL 795 FLUOROMETER/DENSITOMETER | 1992-02-18 | 84 |
| K885254 | V-Tech, Inc. | TARGET READER | 1989-01-27 | 35 |
| K860645 | Helena Laboratories | ELECTROPHORESIS DATA CENTER (EDC) | 1986-12-17 | 300 |
Recalls for JQT devices
openFDA lists no recalls for product code JQT.
Frequently asked questions
What is FDA product code JQT?
JQT is the FDA product code for densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica. It is a Class I device, regulated under 21 CFR 862.2400 and reviewed by the Clinical Chemistry panel.
What device class is JQT?
Class I, regulation 21 CFR 862.2400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQT?
Across 18 cleared submissions the average was 61 days from receipt to decision (median 33).
Which companies have the most JQT clearances?
Corning Medical & Scientific (3); Astral Medical Systems (2); Logos Scientific, Inc. (2); Transidyne General Corp. (2); Arlington Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQT
- Run a recall and safety report across every JQT manufacturer
- Watch product code JQT 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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