Submission Details
| 510(k) Number | K053061 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2005 |
| Decision Date | February 06, 2006 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Feb 2006
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K053061 is an FDA 510(k) clearance for the EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 6, 2006, 98 days after receiving the submission on October 31, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1235.
Device Classification
| Product Code | MKW — Cyclosporine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1235 |
Manufacturer
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