K191245 is an FDA 510(k) clearance for the Yumizen C1200 ALP, Yumizen C1200 Albumin. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on August 30, 2019, 113 days after receiving the submission on May 9, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K191245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2019 |
| Decision Date | August 30, 2019 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJE - Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |