SALIVA SAMPLER
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
SALIVA DIAGNOSTIC SYSTEMS, INC.
The following data is part of a premarket notification filed by Saliva Diagnostic Systems, Inc. with the FDA for Saliva Sampler.
Pre-market Notification Details
| Device ID | K942435 |
| 510k Number | K942435 |
| Device Name: | SALIVA SAMPLER |
| Classification | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Applicant | SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver, WA 98682 |
| Contact | Ronald L Lealos |
| Correspondent | Ronald L Lealos SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver, WA 98682 |
| Product Code | PJD |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1995-08-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937103142 | K942435 | 000 |
| 00840937105108 | K942435 | 000 |
| 00840937105078 | K942435 | 000 |
Trademark Results [SALIVA SAMPLER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALIVA SAMPLER 75339949 2217993 Dead/Cancelled |
Saliva Diagnostic Systems, Inc. 1997-08-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.