The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche C.f.a.s. Dat Qualitative Plus Clinical Calibrator And Control Set Dat Clinical, Models 04590856 190, 04500873 190.
| Device ID | K090939 |
| 510k Number | K090939 |
| Device Name: | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 |
| Classification | Calibrators, Drug Mixture |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Michelle L Neff |
| Correspondent | Michelle L Neff Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2009-06-18 |
| Summary: | summary |