FDA product code KIW: Kit, Mycoplasma Detection
KIW is the FDA product code for kit, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under KIW. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Mycoplasma Detection |
| Device class | Class I |
| Regulation | 21 CFR 864.2360 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIW clearance
Top KIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gibco Laboratories Life Technologies, Inc. | 2 | 1986-03-12 |
Most recent KIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860695 | Gibco Laboratories Life Technologies, Inc. | GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) | 1986-03-12 | 15 |
| K851275 | Gibco Laboratories Life Technologies, Inc. | GIBCO MYCOTECT 189-5670 | 1985-06-21 | 81 |
Recalls for KIW devices
openFDA lists no recalls for product code KIW.
Frequently asked questions
What is FDA product code KIW?
KIW is the FDA product code for kit, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel.
What device class is KIW?
Class I, regulation 21 CFR 864.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIW?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most KIW clearances?
Gibco Laboratories Life Technologies, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KIW
- Run a recall and safety report across every KIW manufacturer
- Watch product code KIW 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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