PJD
- Product code
- PJD
- Device name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
FDA classification definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232898 | 2023-11-21 | Immunalysis Corporation | Quantisal Oral Fluid Collection Device |
Official FDA classification page: PJD
Classification and pathway per current FDA publications. Data from openFDA (CC0).