Submission Details
| 510(k) Number | K073561 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 19, 2007 |
| Decision Date | February 26, 2008 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
Feb 2008
Decision
69d
Days
Class 2
Risk
About This 510(k) Submission
K073561 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 26, 2008, 69 days after receiving the submission on December 19, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | CFN — Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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