The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for C.f.a.s. (calibrator For Automated Systems) Hba1c.
| Device ID | K052101 |
| 510k Number | K052101 |
| Device Name: | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-08-26 |
| Summary: | summary |