PJD

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-21.

NumberDecision dateApplicantDevice nameSummary
K2328982023-11-21Immunalysis CorporationQuantisal™ Oral Fluid Collection DevicePDF

1 summaries are archived here for direct download.

Official FDA classification page: PJD
Classification and pathway per current FDA publications. Data from openFDA (CC0).