FDA product code KIT: Media And Components, Synthetic Cell And Tissue Culture
KIT is the FDA product code for media and components, synthetic cell and tissue culture. It is a Class I device, regulated under 21 CFR 864.2220 and reviewed by the Pathology panel. FDA has cleared 367 510(k) submissions under KIT, from 33 different applicants. The average 510(k) review took 28 days (median 20). FDA has posted 4 recalls for KIT devices.
Classification
| Field | Value |
|---|---|
| Device name | Media And Components, Synthetic Cell And Tissue Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.2220 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIT clearance
Top KIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J R Scientific | 132 | 1988-09-30 |
| Sigma Chemical Co. | 87 | 1988-11-22 |
| Dutchland Laboratories, Inc. | 42 | 1982-07-27 |
| Hazleton Research Products, Inc. | 34 | 1986-06-09 |
| Mediatech, Inc. | 23 | 1986-03-03 |
28 more applicants have KIT clearances. See the full list in Caduvo.
Most recent KIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892938 | Inovar Biologicals, Inc. | AMNIO-GROW TM | 1989-05-22 | 31 |
| K890701 | Clonetics Corp. | ENDOTHELIAL GROWTH MEDIUM (EGM) | 1989-02-24 | 14 |
| K890700 | Clonetics Corp. | MELANOCYTE GROWTH MEDIUM (MGM) | 1989-02-24 | 14 |
| K890482 | Cell Ent., Inc. | ABC, ABC-1X, ABC(TM) | 1989-02-10 | 10 |
| K884654 | Hyclone Laboratories, Inc. | ALPHACALF SERUM | 1988-11-30 | 23 |
Recalls for KIT devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-24.
| Year | Recalls |
|---|---|
| 2018 | 4 |
Frequently asked questions
What is FDA product code KIT?
KIT is the FDA product code for media and components, synthetic cell and tissue culture. It is a Class I device, regulated under 21 CFR 864.2220 and reviewed by the Pathology panel.
What device class is KIT?
Class I, regulation 21 CFR 864.2220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIT?
Across 367 cleared submissions the average was 28 days from receipt to decision (median 20).
Which companies have the most KIT clearances?
J R Scientific (132); Sigma Chemical Co. (87); Dutchland Laboratories, Inc. (42); Hazleton Research Products, Inc. (34); Mediatech, Inc. (23).
Have KIT devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2018-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code KIT
- Run a recall and safety report across every KIT manufacturer
- Watch product code KIT 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