FDA product code JJO: Flame Emission Photometer For Clinical Use
JJO is the FDA product code for flame emission photometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2540 and reviewed by the Clinical Chemistry panel. FDA has cleared 22 510(k) submissions under JJO, from 12 different applicants. The average 510(k) review took 74 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Flame Emission Photometer For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2540 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJO clearance
Top JJO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shaban Mfg. Co. | 6 | 1984-03-30 |
| Reagent Laboratory, Inc. | 3 | 1984-08-17 |
| Corning Medical & Scientific | 3 | 1982-04-01 |
| Instrumentation Laboratory CO | 2 | 1983-01-09 |
| Finnigan Corp. | 1 | 1987-09-22 |
7 more applicants have JJO clearances. See the full list in Caduvo.
Most recent JJO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873603 | Finnigan Corp. | FINNIGAN MAT INCOS 50 | 1987-09-22 | 18 |
| K862148 | Olympus Corp. | OLYMPUS AU 5000 FLAME PHOTOMETER MODULE | 1986-09-29 | 117 |
| K843375 | Logos Scientific, Inc. | ELVI 655 FLAME PHOTOMETER | 1985-05-20 | 265 |
| K841847 | Reagent Laboratory, Inc. | LITHIUM REAGENT | 1984-08-17 | 121 |
| K834226 | Dr. Bruno Lange GmbH | FLAME PHOTOMETERS | 1984-06-22 | 199 |
Recalls for JJO devices
openFDA lists no recalls for product code JJO.
Frequently asked questions
What is FDA product code JJO?
JJO is the FDA product code for flame emission photometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2540 and reviewed by the Clinical Chemistry panel.
What device class is JJO?
Class I, regulation 21 CFR 862.2540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJO?
Across 22 cleared submissions the average was 74 days from receipt to decision (median 46).
Which companies have the most JJO clearances?
Shaban Mfg. Co. (6); Reagent Laboratory, Inc. (3); Corning Medical & Scientific (3); Instrumentation Laboratory CO (2); Finnigan Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJO
- Run a recall and safety report across every JJO manufacturer
- Watch product code JJO 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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