Test, Thromboplastin Generation
The Test, Thromboplastin Generation (product code GKQ) is a hematology coagulation assay used to evaluate the intrinsic pathway of coagulation by measuring the rate and amount of thromboplastin generated from patient plasma, historically applied in the investigation of hemophilia and platelet disorders. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.7900 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GKQ
- Device Class
- FDA class 1
- Regulation Number
- 864.7900
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823520 | FIBROSYSTEM | Dec 28, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.