FDA product code KZK: Reader, Zone, Automated
KZK is the FDA product code for reader, zone, automated. It is a Class I device, regulated under 21 CFR 866.2850 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under KZK, from 2 different applicants. The average 510(k) review took 205 days (median 210).
Classification
| Field | Value |
|---|---|
| Device name | Reader, Zone, Automated |
| Device class | Class I |
| Regulation | 21 CFR 866.2850 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KZK clearance
Top KZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Giles Scientific, Inc. | 2 | 1994-12-15 |
| Intelligence Artificielle Applications | 1 | 1999-11-23 |
Most recent KZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991473 | Intelligence Artificielle Applications | SIRSCAN | 1999-11-23 | 210 |
| K944319 | Giles Scientific, Inc. | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM | 1994-12-15 | 104 |
| K932122 | Giles Scientific, Inc. | BIOMIC VIDEO PLATE READER | 1994-03-01 | 302 |
Recalls for KZK devices
openFDA lists no recalls for product code KZK.
Frequently asked questions
What is FDA product code KZK?
KZK is the FDA product code for reader, zone, automated. It is a Class I device, regulated under 21 CFR 866.2850 and reviewed by the Microbiology panel.
What device class is KZK?
Class I, regulation 21 CFR 866.2850. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZK?
Across 3 cleared submissions the average was 205 days from receipt to decision (median 210).
Which companies have the most KZK clearances?
Giles Scientific, Inc. (2); Intelligence Artificielle Applications (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZK
- Run a recall and safety report across every KZK manufacturer
- Watch product code KZK 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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