FDA product code JJN: Apparatus, Electrophoresis, For Clinical Use
JJN is the FDA product code for apparatus, electrophoresis, for clinical use. It is a Class I device, regulated under 21 CFR 862.2485 and reviewed by the Clinical Chemistry panel. FDA has cleared 34 510(k) submissions under JJN, from 15 different applicants. The average 510(k) review took 71 days (median 42). FDA has posted 1 recall for JJN devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Electrophoresis, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2485 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJN clearance
Top JJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 8 | 1988-07-08 |
| Gelman Sciences, Inc. | 5 | 1984-08-10 |
| Logos Scientific, Inc. | 3 | 1985-01-07 |
| Electrophoresis Corp. of America | 3 | 1980-11-26 |
| Corning Medical & Scientific | 3 | 1980-09-16 |
10 more applicants have JJN clearances. See the full list in Caduvo.
Most recent JJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924021 | The Binding Site, Ltd. | POWER SUPPLY | 1993-01-28 | 170 |
| K924020 | The Binding Site, Ltd. | ELECTROPHORESIS TANK | 1992-12-28 | 139 |
| K882344 | The W.E.P. Co. | ELECTR-TRANSBLOTTER | 1989-01-13 | 220 |
| K881852 | Helena Laboratories | REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 | 1988-07-08 | 67 |
| K882163 | Helena Laboratories | HELENA REP GEL PROCESSOR | 1988-06-20 | 27 |
Recalls for JJN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JJN?
JJN is the FDA product code for apparatus, electrophoresis, for clinical use. It is a Class I device, regulated under 21 CFR 862.2485 and reviewed by the Clinical Chemistry panel.
What device class is JJN?
Class I, regulation 21 CFR 862.2485. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJN?
Across 34 cleared submissions the average was 71 days from receipt to decision (median 42).
Which companies have the most JJN clearances?
Helena Laboratories (8); Gelman Sciences, Inc. (5); Logos Scientific, Inc. (3); Electrophoresis Corp. of America (3); Corning Medical & Scientific (3).
Have JJN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JJN
- Run a recall and safety report across every JJN manufacturer
- Watch product code JJN 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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