FDA product code KJG: Tube, Tissue Culture
KJG is the FDA product code for tube, tissue culture. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KJG. The average 510(k) review took 23 days (median 23). FDA has posted 1 recall for KJG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tissue Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJG clearance
Top KJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corning Medical & Scientific | 1 | 1983-01-05 |
Most recent KJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823747 | Corning Medical & Scientific | 24 CELL WELLS TISSUE CULTURE | 1983-01-05 | 23 |
Recalls for KJG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-19.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code KJG?
KJG is the FDA product code for tube, tissue culture. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KJG?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJG?
Across 1 cleared submissions the average was 23 days from receipt to decision (median 23).
Which companies have the most KJG clearances?
Corning Medical & Scientific (1).
Have KJG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code KJG
- Run a recall and safety report across every KJG manufacturer
- Watch product code KJG 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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