K052101 is an FDA 510(k) clearance for the C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C. This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 26, 2005, 23 days after receiving the submission on August 3, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K052101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2005 |
| Decision Date | August 26, 2005 |
| Days to Decision | 23 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KRZ — Calibrator For Hemoglobin And Hematocrit Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8165 |