510(k) K803081
- Device
- Quanticheck Control Plasma
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K803081
- Product code
- GGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-17
- Date received
- 1980-12-05
- 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 |
|---|---|---|---|
| K800656 | A-GENT QUANTICHROM THROMBIGEN-E | Abbott Laboratories | 1980-05-30 |