510(k) K820084
- Device
- Clotting Time Reagent
- Applicant
- AMERICAN DADE
- 510(k) number
- K820084
- Product code
- GJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-22
- Date received
- 1982-01-12
- Regulation
- 864.7875
- Classification name
- Thrombin
- 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
Source Documents#
510(k) summary PDF not indicated by FDA