Submission Details
| 510(k) Number | K111664 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DIAZYME CYSTATIN C POC TEST KIT
Mar 2012
Decision
290d
Days
Class 2
Risk
About This 510(k) Submission
K111664 is an FDA 510(k) clearance for the DIAZYME CYSTATIN C POC TEST KIT, 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 review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | NDY — Test, Cystatin C |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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