K072270 is an FDA 510(k) clearance for the DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON). 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 February 1, 2008, 170 days after receiving the submission on August 15, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K072270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2007 |
| Decision Date | February 01, 2008 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NDY — Test, Cystatin C |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |