The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Uplink Test System.
| Device ID | K020371 |
| 510k Number | K020371 |
| Device Name: | UPLINK TEST SYSTEM |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | DJG |
| Subsequent Product Code | DIF |
| Subsequent Product Code | JJC |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-04-03 |
| Summary: | summary |