Fibrinogen Determination Standards And Controls
Fibrinogen Determination Standards and Controls (product code GFK) are reference materials used to calibrate and validate laboratory assays that measure plasma fibrinogen concentrations, an important coagulation factor assessed in the diagnosis and monitoring of bleeding disorders and thrombotic conditions. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7340 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GFK
- Device Class
- FDA class 2
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K823388 | TENS MAX | Jan 08, 1983 | Substantially Equivalent | Fujisawa Electronics Co. |
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.