K163078 is an FDA 510(k) clearance for the DC-UIBC-CAL. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on December 8, 2016, 35 days after receiving the submission on November 3, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K163078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2016 |
| Decision Date | December 08, 2016 |
| Days to Decision | 35 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT - Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |