The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Online Dat Ii Methadone Ii.
| Device ID | K021512 |
| 510k Number | K021512 |
| Device Name: | COBAS INTEGRA ONLINE DAT II METHADONE II |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-09 |
| Decision Date | 2002-07-16 |
| Summary: | summary |