FDA product code KJC: Bottle, Roller, Tissue Culture
KJC is the FDA product code for bottle, roller, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under KJC, from 3 different applicants. The average 510(k) review took 29 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Roller, Tissue Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.2240 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJC clearance
Top KJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Motil Plastics , Ltd. | 1 | 1988-04-01 |
| In Vitro Scientific Products | 1 | 1987-08-24 |
| Dynatech Laboratories, Inc. | 1 | 1979-06-28 |
Most recent KJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880509 | Motil Plastics , Ltd. | MULTISURFACE ROLLER BOTTLE (M.S.R.B.) | 1988-04-01 | 51 |
| K873137 | In Vitro Scientific Products | IN VITRO 2.5X ROLLER BOTTLE | 1987-08-24 | 14 |
| K791049 | Dynatech Laboratories, Inc. | SYNALON ROLLER BOTTLE | 1979-06-28 | 22 |
Recalls for KJC devices
openFDA lists no recalls for product code KJC.
Frequently asked questions
What is FDA product code KJC?
KJC is the FDA product code for bottle, roller, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJC?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJC?
Across 3 cleared submissions the average was 29 days from receipt to decision (median 22).
Which companies have the most KJC clearances?
Motil Plastics , Ltd. (1); In Vitro Scientific Products (1); Dynatech Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJC
- Run a recall and safety report across every KJC manufacturer
- Watch product code KJC 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times