The following data is part of a premarket notification filed by Epitope, Inc. with the FDA for Episcreen Oral Specimen Collection Device.
| Device ID | K973395 |
| 510k Number | K973395 |
| Device Name: | EPISCREEN ORAL SPECIMEN COLLECTION DEVICE |
| Classification | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Applicant | EPITOPE, INC. 8505 S.W. CREEKSIDE PLACE Beaverton, OR 97008 |
| Contact | Caroline Sayre |
| Correspondent | Caroline Sayre EPITOPE, INC. 8505 S.W. CREEKSIDE PLACE Beaverton, OR 97008 |
| Product Code | PJD |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-21 |
| Decision Date | 1998-02-13 |
| Summary: | summary |