FDA Product Code PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.
Leading manufacturers include Immunalysis Corporation.
9
Total
9
Cleared
161d
Avg days
1995
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Devices (Product Code PJD)
9 devices
Cleared
Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
Immunalysis Corporation
Chemistry
64d
Cleared
Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
Immunalysis Corporation
Chemistry
224d
About Product Code PJD - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PJD since 1995, with 9 receiving FDA clearance (average review time: 161 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
PJD devices are reviewed by the Chemistry panel. Browse all Chemistry devices →