510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PJDClass II

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

PJD is the FDA product code for Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device, a class II device type, regulated under 21 CFR 862.1675. FDA's definition for this code reads: "Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJD
Device name
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
FDA definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code PJD

By decision year
9 clearances under product code PJD with a decision year between 1995 and 2023, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJD by decision year
YearClearances
19951
19971
19981
19991
20011
20191
20201
20232

Applicants with the most clearances

Product code PJD
Applicants holding the most 510(k) clearances under product code PJD
ApplicantClearances
Immunalysis Corporation4
Epitope, Inc.2
OraSure Technologies, Inc.1
Osborn Laboratories, Inc.1
Saliva Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code