510(k) K072304
- Device
- FIBRINOGEN CALIBRATOR KIT
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K072304
- Product code
- GFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-19
- Date received
- 2007-08-17
- Regulation
- 864.7340
- Classification name
- Fibrinogen Standard
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RADAMES RIESGO
- Address
- P.O. Box 6101; Ms 514 Glasgow Bldg. 500 Newark DE US 19714 19714
FDA Registration Numbers#
- 9610806
- 2032900
Source Documents#
Other 510(k) Records For Product Code GFX #
Legacy Summary#
summary
FDA Review#
Decision Summary