The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Amphetamines Ii Assay.
| Device ID | K093664 |
| 510k Number | K093664 |
| Device Name: | AMPHETAMINES II ASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Michelle L Neff |
| Correspondent | Michelle L Neff ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2010-07-28 |
| Summary: | summary |