Submission Details
| 510(k) Number | K072965 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 2007 |
| Decision Date | December 21, 2007 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
Dec 2007
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K072965 is an FDA 510(k) clearance for the DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on December 21, 2007, 60 days after receiving the submission on October 22, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.
Device Classification
| Product Code | DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5250 |
Manufacturer
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