The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Abuscreen Online Opiates 300 / 2000.
| Device ID | K013482 |
| 510k Number | K013482 |
| Device Name: | ABUSCREEN ONLINE OPIATES 300 / 2000 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2001-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121443 | K013482 | 000 |