510(k) K800656
- Device
- A-gent Quantichrom Thrombigen-e
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K800656
- Product code
- GGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-30
- Date received
- 1980-03-25
- Regulation
- 864.7720
- Classification name
- Test, Prothrombin Consumption
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3004215117
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K803081 | QUANTICHECK CONTROL PLASMA | Abbott Laboratories | 1981-03-17 |