The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Cocaine Metabolite Intercept Micro-plate Eia.
| Device ID | K001197 |
| 510k Number | K001197 |
| Device Name: | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000313 | K001197 | 000 |
| 00608337000306 | K001197 | 000 |
| 00608337000290 | K001197 | 000 |