K191396 is an FDA 510(k) clearance for the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on July 26, 2019, 63 days after receiving the submission on May 24, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K191396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | July 26, 2019 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJY - Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |