Submission Details
| 510(k) Number | K063425 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2006 |
| Decision Date | February 15, 2007 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
Feb 2007
Decision
94d
Days
Class 2
Risk
About This 510(k) Submission
K063425 is an FDA 510(k) clearance for the DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on February 15, 2007, 94 days after receiving the submission on November 13, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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