FDA Product Code
FDA Product Code PJD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1675
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232898 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | 2023-11-21 | Traditional | PDF ↗ |
| K223781 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | 2023-07-28 | Traditional | PDF ↗ |
| K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | 2020-07-28 | Traditional | PDF ↗ |
| K183048 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | 2019-07-29 | Traditional | PDF ↗ |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | OraSure Technologies, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM | Osborn Laboratories, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K973395 | EPISCREEN ORAL SPECIMEN COLLECTION DEVICE | Epitope, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K970357 | EPISCREEN | Epitope, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K942435 | SALIVA SAMPLER | Saliva Diagnostic Systems, Inc. | 1995-08-21 | Traditional | PDF ↗ |
Product code PJD · Class II · Clinical Chemistry. Data: openFDA.