The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Fludi Methamphetamine.
| Device ID | K093884 |
| 510k Number | K093884 |
| Device Name: | ROCHE FLUDI METHAMPHETAMINE |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Michelle Lee Neff |
| Correspondent | Michelle Lee Neff Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LAF |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2011-02-25 |
| Summary: | summary |