The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Phenobarbital, Model 03016757190 & 03510620.
| Device ID | K071644 |
| 510k Number | K071644 |
| Device Name: | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Dimitris Demirtzoglou |
| Correspondent | Dimitris Demirtzoglou ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-15 |
| Decision Date | 2007-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121467 | K071644 | 000 |