Product code DAT— Hematology
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
- Classification name
- Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DAT
FDA has cleared devices under product code DAT between 1978 and 1994, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1994
- 1978
Top applicants under product code DAT
Recent clearances under product code DAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.