510(k) K063655
- Device
- DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K063655
- Product code
- CHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-15
- Date received
- 2006-12-08
- Regulation
- 866.5210
- Classification name
- Immunochemical, Ceruloplasmin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHLEEN DRAY-LYONS
- Address
- P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 9610529
- 9610126
- 3006198300
- 3003795116
- 9610806
Source Documents#
Other 510(k) Records For Product Code CHN #
Legacy Summary#
summary
FDA Review#
Decision Summary