The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Auto-lyte Cocaine Metabolite Eia, Model # 1222u.
| Device ID | K982759 |
| 510k Number | K982759 |
| Device Name: | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1998-11-20 |