DeviceClearance

Product code MIF— Hematology

THROMBONOSTIKA F1.2

Classification name
Prothrombin Fragment 1.2
Device class
Class 2
Regulation
21 CFR 864.7320
Advisory panel
Hematology
Total cleared
6
First cleared
Most recent

Market context for product code MIF

FDA has cleared 6 devices under product code MIF between 1991 and 2004, filed by 5 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

Top applicants under product code MIF

Recent clearances under product code MIF

Data sourced from openFDA. This site is unofficial and independent of the FDA.