The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Opiates Micro-plate Eia (orasure Application).
| Device ID | K981341 |
| 510k Number | K981341 |
| Device Name: | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R S Niedbala |
| Correspondent | R S Niedbala ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000719 | K981341 | 000 |
| 00608337000702 | K981341 | 000 |