The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tdm N-acetylprocainamide.
| Device ID | K060738 |
| 510k Number | K060738 |
| Device Name: | TDM N-ACETYLPROCAINAMIDE |
| Classification | Enzyme Immunoassay, N-acetylprocainamide |
| 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 | LAN |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336147870 | K060738 | 000 |