FDA product code KIZ: Dish, Tissue Culture
KIZ is the FDA product code for dish, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 8 510(k) submissions under KIZ, from 8 different applicants. The average 510(k) review took 36 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Dish, 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 KIZ clearance
Top KIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1989-02-14 |
| Nunc, Inc. | 1 | 1987-11-25 |
| Isratech Marketing Corp. | 1 | 1987-04-29 |
| Lifetrac, Inc. | 1 | 1985-12-13 |
| Corning Medical & Scientific | 1 | 1985-09-16 |
3 more applicants have KIZ clearances. See the full list in Caduvo.
Most recent KIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890542 | Bd Becton Dickinson Vacutainer Systems Preanalytic | MULTIWELL CULTURE PLATE INSERTS | 1989-02-14 | 11 |
| K873891 | Nunc, Inc. | TISSUE CULTURE DISHES | 1987-11-25 | 63 |
| K871483 | Isratech Marketing Corp. | TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES | 1987-04-29 | 14 |
| K854724 | Lifetrac, Inc. | CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE | 1985-12-13 | 21 |
| K853634 | Corning Medical & Scientific | CORNING CELL WELLS-MULTIPLE WELL PLATES | 1985-09-16 | 17 |
Recalls for KIZ devices
openFDA lists no recalls for product code KIZ.
Frequently asked questions
What is FDA product code KIZ?
KIZ is the FDA product code for dish, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KIZ?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIZ?
Across 8 cleared submissions the average was 36 days from receipt to decision (median 19).
Which companies have the most KIZ clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Nunc, Inc. (1); Isratech Marketing Corp. (1); Lifetrac, Inc. (1); Corning Medical & Scientific (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIZ
- Run a recall and safety report across every KIZ manufacturer
- Watch product code KIZ 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