The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Auto-lyte Cotinine Eia.
| Device ID | K972481 |
| 510k Number | K972481 |
| Device Name: | AUTO-LYTE COTININE EIA |
| Classification | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | Sam R Niedbala |
| Correspondent | Sam R Niedbala ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | MKU |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-02 |
| Decision Date | 1997-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000474 | K972481 | 000 |
| 00608337000085 | K972481 | 000 |