K093960 is an FDA 510(k) clearance for the ST AIA-PACK CYSTATIN C, MODEL 025217. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on September 14, 2010, 265 days after receiving the submission on December 23, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K093960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2009 |
| Decision Date | September 14, 2010 |
| Days to Decision | 265 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 |