K163633 is an FDA 510(k) clearance for the cobas HbA1c Test, cobas b 101 system. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Roche Diagnostics Operations (Indianapolis, US). The FDA issued a Cleared decision on July 28, 2017, 218 days after receiving the submission on December 22, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K163633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2016 |
| Decision Date | July 28, 2017 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |