FDA product code KIY: Chamber, Slide Culture
KIY is the FDA product code for chamber, slide culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KIY. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Slide 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 KIY clearance
Top KIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 1 | 1978-09-27 |
Most recent KIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781516 | Zeus Scientific, Inc. | TEST SYSTEM TISSUE CELL CULTURE SLIDE | 1978-09-27 | 27 |
Recalls for KIY devices
openFDA lists no recalls for product code KIY.
Frequently asked questions
What is FDA product code KIY?
KIY is the FDA product code for chamber, slide culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KIY?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIY?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most KIY clearances?
Zeus Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIY
- Run a recall and safety report across every KIY manufacturer
- Watch product code KIY 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