Submission Details
| 510(k) Number | K062182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 2006 |
| Decision Date | September 14, 2006 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
Sep 2006
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K062182 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520, 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 September 14, 2006, 45 days after receiving the submission on July 31, 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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