DeviceClearance

Product code IAB— Hematology

POLYSTAT, BIOLOGICAL STAIN

Classification name
Toluidine Blue
Device class
Class 1
Regulation
21 CFR 864.1850
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

Market context for product code IAB

FDA has cleared 1 device under product code IAB, all in 1985, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code IAB

Recent clearances under product code IAB

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