FDA product code KIQ: Kit, Culture, Chromosome
KIQ is the FDA product code for kit, culture, chromosome. It is a Class I device, regulated under 21 CFR 864.2260 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KIQ. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Culture, Chromosome |
| Device class | Class I |
| Regulation | 21 CFR 864.2260 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIQ clearance
Top KIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmacia Fine Chemicals | 1 | 1979-03-08 |
Most recent KIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790239 | Pharmacia Fine Chemicals | PHYTOHAEMAGGLUTININ | 1979-03-08 | 35 |
Recalls for KIQ devices
openFDA lists no recalls for product code KIQ.
Frequently asked questions
What is FDA product code KIQ?
KIQ is the FDA product code for kit, culture, chromosome. It is a Class I device, regulated under 21 CFR 864.2260 and reviewed by the Pathology panel.
What device class is KIQ?
Class I, regulation 21 CFR 864.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIQ?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most KIQ clearances?
Pharmacia Fine Chemicals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIQ
- Run a recall and safety report across every KIQ manufacturer
- Watch product code KIQ 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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