PJD
9 FDA 510(k) clearances · Product code
123 daysmedian time to decision
458 days90th percentile
9clearances measured
FDA profile
- Official device name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- FDA definition
- Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Quantisal™ Oral Fluid Collection Device (K232898) | Immunalysis Corporation | 2023-11-21 |
| Quantisal™ II Oral Fluid Collection Device (K223781) | Immunalysis Corporation | 2023-07-28 |
| Quantisal Oral Fluid Collection Device (K200801) | Immunalysis Corporation | 2020-07-28 |
| Quantisal II Oral Fluid Collection Device (K183048) | Immunalysis Corporation | 2019-07-29 |
| INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057) | OraSure Technologies, Inc. | 2001-06-06 |
| ORAL-EZE ORAL FLUID COLLECTION SYSTEM (K984361) | Osborn Laboratories, Inc. | 1999-01-13 |
| EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395) | Epitope, Inc. | 1998-02-13 |
| EPISCREEN (K970357) | Epitope, Inc. | 1997-03-10 |
| SALIVA SAMPLER (K942435) | Saliva Diagnostic Systems, Inc. | 1995-08-21 |
Track PJD automatically
Every clearance here is in the API, with alerts when new ones post.