The following data is part of a premarket notification filed by Osborn Laboratories, Inc. with the FDA for Oral-eze Oral Fluid Collection System.
| Device ID | K984361 |
| 510k Number | K984361 |
| Device Name: | ORAL-EZE ORAL FLUID COLLECTION SYSTEM |
| Classification | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Applicant | OSBORN LABORATORIES, INC. 14901 WEST 117 ST. Olathe, KS 66062 |
| Contact | Gilbert P Bourk Iii |
| Correspondent | Gilbert P Bourk Iii OSBORN LABORATORIES, INC. 14901 WEST 117 ST. Olathe, KS 66062 |
| Product Code | PJD |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-01-13 |
| Summary: | summary |