510(k) K812628
- Device
- Aca Fibrinogen Calibrator
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K812628
- Product code
- GFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-24
- Date received
- 1981-09-15
- Regulation
- 864.7340
- Classification name
- Fibrinogen Standard
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610806
- 2032900
Source Documents#
510(k) summary PDF not indicated by FDA