Submission Details
| 510(k) Number | K063610 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 04, 2006 |
| Decision Date | January 11, 2007 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
Jan 2007
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K063610 is an FDA 510(k) clearance for the DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on January 11, 2007, 38 days after receiving the submission on December 4, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.
Device Classification
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5130 |
Manufacturer
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