The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Carbamazepine Gen 4.
| Device ID | K151578 |
| 510k Number | K151578 |
| Device Name: | Carbamazepine Gen 4 |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | David Tribbett |
| Correspondent | David Tribbett Roche Diagnostics Operations (RDO) 9115 Hague Road 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 | 2015-06-11 |
| Decision Date | 2015-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121108 | K151578 | 000 |