Panels › Clinical Chemistry › Product code PJD · Class 2
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Regulation 862.1675
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PJD
| Company | 510(k)s | Recalls |
|---|---|---|
| Immunalysis Corporation | 4 | 0 |
| Epitope, Inc. | 2 | 0 |
| OraSure Technologies, Inc. | 1 | 0 |
| Osborn Laboratories, Inc. | 1 | 0 |
| Saliva Diagnostic Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2023 | K232898 | Quantisal Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jul 28, 2023 | K223781 | Quantisal II Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jul 28, 2020 | K200801 | Quantisal Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jul 29, 2019 | K183048 | Quantisal II Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jun 6, 2001 | K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX OraSure Technologies, Inc. | PJD |
| Jan 13, 1999 | K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM Osborn Laboratories, Inc. | PJD |
| Feb 13, 1998 | K973395 | EPISCREEN ORAL SPECIMEN COLLECTION DEVICE Epitope, Inc. | PJD |
| Mar 10, 1997 | K970357 | EPISCREEN Epitope, Inc. | PJD |
| Aug 21, 1995 | K942435 | SALIVA SAMPLER Saliva Diagnostic Systems, Inc. | PJD |
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