The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Online Tdm Phenytoin.
| Device ID | K030428 |
| 510k Number | K030428 |
| Device Name: | ROCHE ONLINE TDM PHENYTOIN |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Mike Flis |
| Correspondent | Mike Flis ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336157787 | K030428 | 000 |
| 07613336121474 | K030428 | 000 |
| 04015630999378 | K030428 | 000 |
| 04015630997763 | K030428 | 000 |