FDA product code KPB: Media And Components, Mycoplasma Detection
KPB is the FDA product code for media and components, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under KPB, from 2 different applicants. The average 510(k) review took 40 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Media And Components, 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 KPB clearance
Top KPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Flow Laboratories, Inc. | 3 | 1978-12-20 |
| Bioassay Systems Research Corp. | 1 | 1977-11-17 |
Most recent KPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781874 | Flow Laboratories, Inc. | MYCOPLASMA ARGININI FITC (30-403-41) | 1978-12-20 | 47 |
| K781875 | Flow Laboratories, Inc. | STAIN KIT FOR CELL CULTURES (30-100-00) | 1978-12-20 | 47 |
| K781390 | Flow Laboratories, Inc. | MYCOPLASMA HYORHINIS (BTS-7) | 1978-09-01 | 22 |
| K771867 | Bioassay Systems Research Corp. | MYCOPLASMA DETECTION KIT | 1977-11-17 | 45 |
Recalls for KPB devices
openFDA lists no recalls for product code KPB.
Frequently asked questions
What is FDA product code KPB?
KPB is the FDA product code for media and components, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel.
What device class is KPB?
Class I, regulation 21 CFR 864.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPB?
Across 4 cleared submissions the average was 40 days from receipt to decision (median 46).
Which companies have the most KPB clearances?
Flow Laboratories, Inc. (3); Bioassay Systems Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPB
- Run a recall and safety report across every KPB manufacturer
- Watch product code KPB 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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