The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Oti Benzodiazepines Intercept Micro-plate Eia Model #1110i.
| Device ID | K013882 |
| 510k Number | K013882 |
| Device Name: | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000252 | K013882 | 000 |
| 00608337000245 | K013882 | 000 |
| 00608337000238 | K013882 | 000 |