The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Tdm Carbamazepine.
| Device ID | K031902 |
| 510k Number | K031902 |
| Device Name: | ONLINE TDM CARBAMAZEPINE |
| Classification | Enzyme Immunoassay, Carbamazepine |
| 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 | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-20 |
| Decision Date | 2003-09-17 |
| Summary: | summary |