Submission Details
| 510(k) Number | K061503 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2006 |
| Decision Date | June 22, 2006 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
Jun 2006
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K061503 is an FDA 510(k) clearance for the DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A), a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 22, 2006, 21 days after receiving the submission on June 1, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.
Device Classification
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3200 |
Manufacturer
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