510(k) K803081
K803081 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "QUANTICHECK CONTROL PLASMA". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code GGQ (Test, Prothrombin Consumption), a Class II device regulated under 21 CFR 864.7720. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1981
- Date Received
- December 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Prothrombin Consumption
- Device Class
- Class II
- Regulation Number
- 864.7720
- Review Panel
- HE
- Submission Type