510(k) K994341
- Device
- Fibrinogen Calibrator Kit
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K994341
- Product code
- GFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-03
- Date received
- 1999-12-23
- 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
- REBECCA S AYASH
- Address
- P.O. Box 6101 Glasgow Bldg. 500 Newark DE US 19714 19714
FDA Registration Numbers#
- 9610806
- 2032900