The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Control Set Dat I, Contrl Set Dat Ii, Control Set Dat Iii, Control Set Amphetamine 1000 And Control Set Amphetamine 500.
| Device ID | K080183 |
| 510k Number | K080183 |
| Device Name: | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 |
| Classification | Drug Mixture Control Materials |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Dimitris Demirtzoglou |
| Correspondent | Dimitris Demirtzoglou ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-03-25 |
| Summary: | summary |