K111664 is an FDA 510(k) clearance for the DIAZYME CYSTATIN C POC TEST KIT. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on March 30, 2012, 290 days after receiving the submission on June 14, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K111664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2011 |
| Decision Date | March 30, 2012 |
| Days to Decision | 290 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 |