K181082 is an FDA 510(k) clearance for the ADVIA Chemistry Cystatin C_2 Assay (CYSC_2). This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on May 25, 2018, 31 days after receiving the submission on April 24, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K181082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2018 |
| Decision Date | May 25, 2018 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDY — Test, Cystatin C |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |