Submission Details
| 510(k) Number | K063647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2006 |
| Decision Date | March 12, 2007 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
Mar 2007
Decision
95d
Days
Class 2
Risk
About This 510(k) Submission
K063647 is an FDA 510(k) clearance for the CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on March 12, 2007, 95 days after receiving the submission on December 7, 2006. 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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