Submission Details
| 510(k) Number | K062199 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 2006 |
| Decision Date | September 06, 2006 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
Sep 2006
Decision
36d
Days
Class 2
Risk
About This 510(k) Submission
K062199 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430), 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 6, 2006, 36 days after receiving the submission on August 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 |
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