510(k) K060677
- Device
- N LATEX CDT
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K060677
- Product code
- NAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-25
- Date received
- 2006-03-14
- Regulation
- 862.1360
- Classification name
- Test, Carbohydrate Deficient Transferrin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- 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#
- 9610806
- 3014325803
- 8023024
Source Documents#
Other 510(k) Records For Product Code NAO #
Legacy Summary#
summary
FDA Review#
Decision Summary